Arthrex® AR-503-A510Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867103818), received between Mar 31, 2017 and Mar 31, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2017Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL KNEE PROCEDURE ON (B)(6) 2017 DURING WHICH THE FOLLOWING COMPONENTS WERE IMPLANTED: AR-503-A510 ((B)(6), MEDWATCH 1220246-2017-00103), AR-504-PSC9 ((B)(6)- MEDWATCH 1220246-2017-00104), AR-513-T5 ((B)(6)- MEDWATCH 1220246-2017-00105) AND AR-517-6R ((B)(6)- MEDWATCH 1220246-2017-00106). POST-OP I&D (IRRIGATION AND DEBRIDEMENT) DONE ON (B)(6) 2017, PUS WAS FOUND INSIDE THE KNEE. ALL IMPLANTS WERE EXPLANTED AND REPLACED WITH CEMENT SPACER MIXED WITH ANTIBIOTICS. MALE (B)(6). ADDITIONAL INFORMATION OBTAINED ON (B)(4) 2017: IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT BEGAN EXPERIENCING MARKED AND SEVERE WELLING AND SPONTANEOUS DRAINING. AT SURGEON OFFICE SAME DAY CULTURES WERE TAKEN AND WERE POSITIVE FOR AN UNSPECIFIED INFECTION DISEASE. ON (B)(6) 2017, PATIENT WENT IN FOR A POST OP I&D AND PUS WAS FOUND INSIDE PATIENT KNEE. DEVICES WERE THEN EXPLANTED. PATIENT WAS KEPT OVERNIGHT AND DISCHARGED ON (B)(6) 2017. CULTURE/PATHOLOGY WAS PERFORMED DURING REVISION. RESULTS HAVE NOT BEEN PROVIDED. PATIENT IS EXPECTED TO HAVE CEMENT SPACERS LEFT IN 3-6 MONTH, AFTER WHICH SURGEON WILL MOST LIKELY USE ANOTHER MANUFACTURER'S PRODUCT. PATIENT WILL NEED B

  Patient problems: Joint Swelling; Post Operative Wound Infection

  MAUDE report 6450272 ↗