STARRecalls & reported problems across all models
Stryker GmbH · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 148
- Deaths reported
- 0
- Injuries reported
- 140
- Recalls
- 0
We found 22 models of STAR by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 148 adverse event reports in the FDA's MAUDE database, received between Aug 28, 2015 and Apr 20, 2026 — classified as 140 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (23 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported STAR problems
Device problems
- Adverse Event Without Identified Device or Use Problem92
- Fracture23
- Break12
- Unstable6
- Device Dislodged or Dislocated4
- Inadequacy of Device Shape and/or Size4
- Naturally Worn4
- Patient Device Interaction Problem4
Patient problems
- Failure of Implant30
- Insufficient Information27
- Implant Pain20
- Unspecified Infection19
- Pain13
- Joint Laxity10
- No Known Impact Or Consequence To Patient8
- Injury7
STAR models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- STAR 400-140FProsthesis, Ankle, Uncemented, Non-Constrained27 reports
- STAR 400-141FProsthesis, Ankle, Uncemented, Non-Constrained24 reports
- STAR 400-142FProsthesis, Ankle, Uncemented, Non-Constrained23 reports
- STAR 400-263Prosthesis, Ankle, Uncemented, Non-Constrained11 reports
- STAR 400-144FProsthesis, Ankle, Uncemented, Non-Constrained11 reports
- STAR™ 400-143FProsthesis, Ankle, Uncemented, Non-Constrained10 reports
- STAR 400-254Prosthesis, Ankle, Uncemented, Non-Constrained7 reports
- STAR 400-262Prosthesis, Ankle, Uncemented, Non-Constrained6 reports
- STAR 400-264Prosthesis, Ankle, Uncemented, Non-Constrained5 reports
- STAR™ 99-0028/11FProsthesis, Ankle, Uncemented, Non-Constrained5 reports
- STAR 920-0061Prosthesis, Ankle, Uncemented, Non-Constrained4 reports
- STAR™ 400-252Prosthesis, Ankle, Uncemented, Non-Constrained3 reports
- STAR™ 400-253Prosthesis, Ankle, Uncemented, Non-Constrained2 reports
- STAR 99-0028/12FProsthesis, Ankle, Uncemented, Non-Constrained2 reports
- STAR 100-0071Prosthesis, Ankle, Uncemented, Non-Constrained1 report
- STAR™ 400-250Prosthesis, Ankle, Uncemented, Non-Constrained1 report
- STAR 400-255Prosthesis, Ankle, Uncemented, Non-Constrained1 report
- STAR 400-257Prosthesis, Ankle, Uncemented, Non-Constrained1 report
- STAR 908-0165Prosthesis, Ankle, Uncemented, Non-Constrained1 report
- STAR™ 925-0016Prosthesis, Ankle, Uncemented, Non-Constrained1 report
- STAR 933-0003Prosthesis, Ankle, Uncemented, Non-Constrained1 report
- STAR™ 99-0028/14FProsthesis, Ankle, Uncemented, Non-Constrained1 report
Recent STAR adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 20, 2026Unstable
InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24933084 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24933083 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24780720 ↗InjuryApr 3, 2026Patient Device Interaction Problem
InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24772721 ↗InjuryApr 1, 2026Patient Device Interaction Problem
InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 1, 2026Patient Device Interaction Problem
InjuryMar 25, 2026Unstable
REVISION SURGERY - DUE TO INSTABILITY AND WEAR.
Patient problems: Joint Laxity
MAUDE report 24683787 ↗InjuryMar 25, 2026Unstable
REVISION SURGERY - DUE TO INSTABILITY AND WEAR.
Patient problems: Joint Laxity
MAUDE report 24683611 ↗InjuryMar 25, 2026Patient Device Interaction Problem
Other Stryker GmbH products
All Stryker GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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