Arthrex® AR-513-BH12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867107571), received between Oct 18, 2019 and Dec 12, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2019Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY THE PATIENT THAT HE HAD TOTAL KNEE RECONSTRUCTION ON (B)(6) 2015. ABOUT TWO YEARS AGO THE PATIENT STARTED EXPERIENCING PAIN IN THE KNEE. PER THE PATIENT, X-RAYS WERE TAKEN AND IT WAS DETERMINED THE KNEE IS NOW LOOSE. PATIENT IS SCHEDULED FOR A REVISION LEFT TKA SURGERY ON (B)(6) 2019. ADDITIONAL INFORMATION OBTAINED 10/10/19: THE PATIENT HAD UNDERGONE A BI-LATERAL TKA PROCEDURE ON (B)(6) 2015. PATIENT REPORTED THAT BONE SCANS WERE TAKEN WHICH CONFIRMED HIS LEFT TIBIAL IMPLANT TO BE LOOSE. PATIENT STATED HE HAS DEALT WITH THE PAIN AND ACCOMPANYING ISSUES FOR OVER TWO YEARS, TAKING 1000 MG OF TYLENOL AND 800 MG OF IBUPROFEN DAILY OVER PAST SEVERAL YEARS, BUT REPORTS HIS LEG IS NOW BOWED AND CAUSING SCIATICA TYPE PAIN IN HIS HIP. DURING THE (B)(6) 2015 ORIGINAL PROCEDURE THE PATIENT HAD THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED IN HIS LEFT KNEE: AR-503-TTTH, TIBIAL TRAY IMPLANT (LOT 1358298), AR-516-7L, FEMORAL IMPLANT (LOT 1373719), AR-513-BH12, BEARING IMPLANT (LOT 113601409), AR-504-PSD0, PATELLA IMPLANT (LOT 113601430). ADDITIONAL INFORMATION OBTAINED 11/19/19: CONFIRMATION WAS RECEIVED THAT THE PATIENT'S LEFT TKA REVISION PROCEDURE TOOK PLACE AS SCHEDULED ON

  Patient problems: Pain

  MAUDE report 9457413 ↗
• 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 9207328 ↗