Arthrex® AR-516-7RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867109391), received between Nov 21, 2016 and May 18, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2021Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT¿S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE PROCEDURE ON (B)(6) 2014, AND IS EXPERIENCING UNKNOWN ISSUES WITH THE KNEE REPLACEMENT. THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE PRIMARY PROCEDURE: AR-503-TTTH (LOT: 780842), AR-516-7R (LOT: 108761412) X 2, AR-513-BH10 (LOT: 113601339), AR-504-PSD0 (LOT: 113601323). TO DATE NO REVISION HAS BEEN REPORTED. THE PATIENT ALSO HAD A LEFT TOTAL KNEE PROCEDURE ON (B)(6) 2014 WHICH WAS REVISED ON (B)(6) 2019 (SEE CASE (B)(4)). ADDITIONAL INFORMATION RECEIVED ON 4/26/2021: ARTHREX HAS RECEIVED CONFIRMATION THAT THE PATIENT'S RIGHT KNEE WAS REVISED ON (B)(6) 2021. NO ADDITIONAL DETAILS PERTAINING TO THE REVISION SURGERY HAVE BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 11841746 ↗
• InjuryNov 4, 2019Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT HAD UNDERGONE A BI-LATERAL TKA PROCEDURE. ON (B)(6) 2019 THE PATIENT UNDERWENT A REVISION RIGHT TKA PROCEDURE DUE TO PAIN AND TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE FOLLOWING ORIGINAL ARTHREX IMPLANT DEVICES WERE EXPLANTED: AR-503-TTTG, TIBIAL TRAY IMPLANT (LOT 108761215), AR-516-7R, FEMORAL IMPLANT (LOT 108761338), AR-513-BG11, TIBIAL BEARING IMPLANT (LOT 113601405), AR-504-PSC9, PATELLA IMPLANT (LOT 113601430). THE REVISION PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER MANUFACTURER'S DEVICES.

  Patient problems: Pain

  MAUDE report 9272301 ↗
• InjuryOct 18, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A RIGHT TKA PROCEDURE ON (B)(6) 2015. DURING THE ORIGINAL PROCEDURE THE PATELLA WAS RESURFACED. THE PATIENT WAS EXPERIENCING PAIN AND UNDERWENT A REVISION RIGHT TKA PROCEDURE ON (B)(6) 2019. THE REVISION PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER MANUFACTURER'S PRODUCT. DURING THE REVISION THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED: TIBIAL TRAY IMPLANT, AR-503-TTTH, LOT 1337240, FEMORAL IMPLANT, AR-516-7R, LOT 108761331, BEARING IMPLANT, AR-513-BH12, LOT 113601409, PATELLA IMPLANT, AR-504-PSC9, LOT 113601430.

  Patient problems: Pain

  MAUDE report 9207321 ↗
• InjuryNov 21, 2016Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2015 A PATIENT UNDERWENT A RIGHT TKA PROCEDURE. ON (B)(6) 2016 THE SURGEON PERFORMED A REVISION RIGHT TKA PROCEDURE DUE TO PATIENT PAIN. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTH , LOT 108761152 ((B)(4)(B)(6)), FEMORAL IMPLANT AR-516-7R, LOT 108761338 ((B)(4)(B)(6)), BEARING IMPLANT AR-513-BH11, LOT 113601408 ((B)(4)(B)(6)) AND PATELLA IMPLANT AR-504-PSD0, LOT 113601430 ((B)(4)(B)(6)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, DOB (B)(6) 1969, AGE (B)(6). PATIENT MEDICAL RECORDS DATE (B)(6) 2016 NOTED: EXAMINATION OF THE RIGHT KNEE DEMONSTRATED NO ERYTHEMA AND NO ECCHYMOSIS. PALPATION OF THE RIGHT KNEE DEMONSTRATED INFERIOR PATELLA POLE TENDERNESS, MEDIAL JOINT LINE TENDERNESS, LATERAL JOINT LINE TENDERNESS AND MEDIAL TIBIAL PLATEAU TENDERNESS. TRACE EFFUSION OF THE RIGHT KNEE WAS NOTED. RECORDS NOTED PATIENT HAD PAIN TROUGH A LIMITED PASSIVE RANGE OF MOTION WITH CREPITUS AND SWELLING. X-RAYS WERE NOTED TO SHOW PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING.

  Patient problems: Joint Swelling; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 6117795 ↗