Arthrex® AR-5051-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867217614), received between Sep 10, 2025 and Sep 12, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Biocompatibility” (2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2025Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT REPORTED VIA EMAIL THAT THEY HAD UNDERGONE PATELLA REPAIR SURGERY ON (B)(6) 2022, DURING WHICH TWO AR-5051-38 LOW PROFILE SCREWS (CANNULATED, BLUNT TIP, 4 X 38 MM) WERE IMPLANTED. THE PATIENT BEGAN EXPERIENCING A SYSTEMIC REACTION APPROXIMATELY NINE MONTHS POSTOPERATIVELY, WHICH HAS PERSISTED TO THE PRESENT DAY. TO SUPPORT FUTURE HEALTHCARE AND TREATMENT DECISIONS, THE PATIENT HAS REQUESTED THE METALLURGICAL COMPOSITION OF THE IMPLANTED SCREWS. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 08/28/2025: ON (B)(6) 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE TO TREAT A TRANSVERSE DISPLACED FRACTURE OF THE LEFT PATELLA. THE INJURY OCCURRED ON (B)(6) 2022, WHEN THE PATIENT FELL WHILE ASCENDING CARPETED STAIRS AT AN AIRPORT WHILE CARRYING A BACKPACK. BENEATH THE CARPETING WAS A METAL EDGE, WHICH CAUSED A DIRECT IMPACT TO THE LEFT KNEE FROM AN ESTIMATED HEIGHT OF 12¿14 INCHES, RESULTING IN THE FRACTURE. DURING THE PROCEDURE, TWO AR-5051-38 LOW PROFILE SCREWS WERE IMPLANTED. HOWEVER, THE LOT NUMBERS FOR THESE SCREWS REMAIN UNKNOWN, AND IT IS CURRENTLY UNCLEAR WHETHER ADDITIONAL ARTHREX COMPONENTS WERE USED. APPROXIMATELY NINE

  Patient problems: Hypersensitivity/Allergic reaction; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 23038675 ↗
• InjurySep 10, 2025Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT REPORTED VIA EMAIL THAT THEY HAD UNDERGONE PATELLA REPAIR SURGERY ON (B)(6) 2022, DURING WHICH TWO AR-5051-38 LOW PROFILE SCREWS (CANNULATED, BLUNT TIP, 4 X 38 MM) WERE IMPLANTED. THE PATIENT BEGAN EXPERIENCING A SYSTEMIC REACTION APPROXIMATELY NINE MONTHS POSTOPERATIVELY, WHICH HAS PERSISTED TO THE PRESENT DAY. TO SUPPORT FUTURE HEALTHCARE AND TREATMENT DECISIONS, THE PATIENT HAS REQUESTED THE METALLURGICAL COMPOSITION OF THE IMPLANTED SCREWS. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 08/28/2025: ON (B)(6) 2022, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) PROCEDURE TO TREAT A TRANSVERSE DISPLACED FRACTURE OF THE LEFT PATELLA. THE INJURY OCCURRED ON (B)(6) 2022, WHEN THE PATIENT FELL WHILE ASCENDING CARPETED STAIRS AT AN AIRPORT WHILE CARRYING A BACKPACK. BENEATH THE CARPETING WAS A METAL EDGE, WHICH CAUSED A DIRECT IMPACT TO THE LEFT KNEE FROM AN ESTIMATED HEIGHT OF 12¿14 INCHES, RESULTING IN THE FRACTURE. DURING THE PROCEDURE, TWO AR-5051-38 LOW PROFILE SCREWS WERE IMPLANTED. HOWEVER, THE LOT NUMBERS FOR THESE SCREWS REMAIN UNKNOWN, AND IT IS CURRENTLY UNCLEAR WHETHER ADDITIONAL ARTHREX COMPONENTS WERE USED. APPROXIMATELY NINE

  Patient problems: Hypersensitivity/Allergic reaction; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 23020538 ↗