STAR™ 99-0028/11FRecalls & reported problems
Stryker GmbH · Sliding Core, UHMPWE, 11mm REVISION · Class 3 · Implant
All models of STAR (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886385026978), received between Apr 16, 2021 and Mar 25, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Unstable” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Unstable1
Patient problems
- Unspecified Infection3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Impaired Healing1
- Insufficient Information1
- Joint Laxity1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2026Unstable
REVISION SURGERY - DUE TO INSTABILITY AND WEAR.
Patient problems: Joint Laxity
MAUDE report 24683787 ↗InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 02/16/2023, AN INDEPENDENT SALES REPRESENTATIVE, SUBMITTED AN EMAIL WITH A REVISION SURGERY CASE SHEET FOR A 99-0028-11F (REVISION SLIDING CORE STAR ANKLE 11MM) ON A 67 YEAR OLD MALE PATIENT. PER THE FORM, THE REVISION SURGERY TOOK PLACE AS THE "PATIENT WAS BROUGHT TO SURGERY FOR A LATERAL GUTTER DEBRIEDMENT. SURGEON PERFORMED A POLY BEARING SWAP AT THE TIME OF SURGERY" AND ALSO STATED THE POLY SWAP WAS "REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE (REVISION)". THERE WAS NO DELAY IN THE SURGERY AND NO RISK OR ADVERSE EVENT OCCURRED. THE SURGERY WAS COMPLETED AS INTENDED, AND THE 99-0028-11F WAS DISCARDED AND WILL NOT BE RETURNED FOR FURTHER EVALUATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 16559194 ↗InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "I HAD ISSUES WITH THE STAR ANKLE REPLACEMENT AS SOON AS IT WAS PUT IN. THE CENTER PIECE KEPT BREAKING AND CAUSING FRACTURES. I HAD MULTIPLE REVISIONS AND HAD TO HAVE MY LEG AMPUTATED." PER MEDICAL RECORDS RECEIVED FROM THE PATIENT ON (B)(6), 2021 THE EVENT IS AS FOLLOW: (B)(6)2015 : ANTERIOR ANKLE ARTHROTOMY WITH REMOVAL OF TOTAL ANKLE IMPLANT WITH BONE CULTURE AND BIOPSY. ¿ 5TH INTERVENTION
Patient problems: Impaired Healing; Unspecified Infection
MAUDE report 11689399 ↗InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "I HAD ISSUES WITH THE STAR ANKLE REPLACEMENT AS SOON AS IT WAS PUT IN. THE CENTER PIECE KEPT BREAKING AND CAUSING FRACTURES. I HAD MULTIPLE REVISIONS AND HAD TO HAVE MY LEG AMPUTATED." PER MEDICAL RECORDS RECEIVED FROM THE PATIENT ON (B)(6), 2021 THE EVENT IS AS FOLLOW: (B)(6) 2015 : LATERAL ANKLE ARTHROTOMY WITH BONE CULTURES AND IRRIGATION OF RIGHT ANKLE - 2ND INTERVENTION
Patient problems: Unspecified Infection
MAUDE report 11679162 ↗
Other Prosthesis, Ankle, Uncemented, Non-Constrained devices
- STAR 400-140FStryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained27 reports
- STAR 400-141FStryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained24 reports
- STAR 400-142FStryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained23 reports
- STAR 400-263Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained11 reports
- STAR 400-144FStryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained11 reports
- STAR™ 400-143FStryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained10 reports
- STAR 400-254Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained7 reports
- STAR 400-262Stryker GmbH · Prosthesis, Ankle, Uncemented, Non-Constrained6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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