Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)
[INJURY]Nov 11, 2020 · Stryker · Stryker Mako SmartRobotics · Global
Failure Mode
INJURY
Event Date
Nov 11, 2020
Primary Entity
Stryker
Robotic Platform
Stryker Mako SmartRobotics
Jurisdiction / Location
Global
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
An FDA MAUDE injury report describes a Stryker Mako patient with persistent instability and pain requiring revision, attributed to mechanical loosening and bone over-resection. Source: FDA MAUDE MDR key 19203776, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
- Inspect Filing
https://www.stryker.com/
https://www.stryker.com/
- Inspect Filing
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=21274950&pc=OLO
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=21274950&pc=OLO
Related Incidents & Failure Precedents
6 records on file- Woman sues Starship after delivery robot knocked her down, causing spinal fracture[INJURY]
Jul 25, 2026 · Starship Technologies · Starship Bot · Greater Manchester/Trafford, United Kingdom
Details - Starship delivery robot strikes ASU employee on campus, lawsuit filed[INJURY]
Jul 25, 2026 · Starship Technologies · Starship Bot · Greater Manchester/Trafford, United Kingdom
Details - Drone falls into stands at Ponoka Stampede, injuring two people[INJURY]
Jul 10, 2026 · DJI · DJI Mavic 3 Pro · Global
Details - Unitree G1 robot kicks child during amusement park performance in China[INJURY]
Jun 8, 2026 · Unitree Robotics · Unitree Go2 · Global
Details - Unitree G1 humanoid robot roundhouse-kicked a child in the stomach during a martial arts demo at Urumqi Botanical Garden[INJURY]
Jun 1, 2026 · Unitree Robotics · Unitree Go2 · Global
Details - Shield AI V-BAT drone propeller severs Romanian Navy official's fingers during training exercise off Texas coast[INJURY]
May 12, 2026 · Shield AI · Shield AI V-BAT · San Diego, CA
Details
Incident Context & FAQ
What happened in Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)?
An FDA MAUDE injury report describes a Stryker Mako patient with persistent instability and pain requiring revision, attributed to mechanical loosening and bone over-resection. Source: FDA MAUDE MDR key 19203776, openFDA device event / accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE.
When did this incident occur?
The incident is recorded as occurring on November 11, 2020 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)?
Stryker Mako SmartRobotics by Stryker is the recorded robot involved in this incident at Global.
Has anyone responded to Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Stryker Mako: persistent instability and pain requiring revision after over-resection (FDA MAUDE)?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.