SPECIALIST 9505-01-024Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295224266), received between Mar 27, 2018 and Nov 25, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Issue” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATELLA PROTECTOR BECAME DISLODGED DUE TO SPIKES ON POSTERIOR ASPECT NOT BEING LONG ENOUGH TO GRAB BONE TO BE IN PLACE FOR THE ENTIRE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9371838 ↗
• InjuryAug 10, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE NURSE AT THE GAVE THE SALES REP A METAL DEPUY PATELLA WAFER. THEY HAD JUST REMOVED IT FROM A PATIENT. IT WAS ACCIDENTALLY IMPLANTED/RETAINED IN SAID PATIENT ROUGHLY 2 MONTHS EARLIER DURING PRIMARY TKA. APPARENTLY IT WAS NOT NOTICED UNTIL THE PATIENT WAS BACK FOR A FOLLOW-UP POST-OP XRAY.

  Patient problems: Not Applicable

  MAUDE report 7771845 ↗
• InjuryMar 27, 2018Device Issue; Appropriate Device Problem Term/Code Not Available; Device Issue; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT THE SP2 MI PATELLA WAFER HAD DISASSOCIATED AFTER BEING APPLIED TO PREPARED PATELLA SURFACE AT SOME POINT DURING THE PROCEDURE (PATELLA WAS PREPARED FIRST). THE WAFER MIGRATED TO SUPERIOR LATERAL CAPSULE AND WAS RETAINED IN THE WOUND AFTER CLOSURE. THE RETAINED INSTRUMENT WAS IDENTIFIED BY A FILM TAKEN IN (B)(6) AND THE INSTRUMENT WAS SUBSEQUENTLY RETRIEVED DURING A SEPARATE PROCEDURE THREE HOURS POST OP OF THE TKA.

  Patient problems: No Code Available; No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7373205 ↗