Arthrex® AR-502-1LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867034372), received between May 18, 2017 and May 18, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2017Malposition of Device

  IT WAS REPORTED THAT A PATIENT HAD INQUIRED THROUGH THE ARTHREX WEBSITE ABOUT THE MATERIAL COMPOSITION OF AN ARTHREX PFJ FEMORAL 1L IMPLANT WHICH SHE STATES WAS IMPLANTED IN HER BODY. PATIENT DID NOT HAVE THE SPECIFIC PART NUMBER AND STATES SHE NO LONGER HAS CONTACT WITH THE PHYSICIAN THAT ORIGINALLY IMPLANTED THE DEVICE. PATIENT WAS INSTRUCTED THAT TO PROVIDE A CONFIRMED MATERIAL COMPOSITION FOR HER SPECIFIC IMPLANT SHE WOULD NEED TO OBTAIN THE ORIGINAL IMPLANT PART NUMBERS FROM THE SURGICAL FACILITY AND PROVIDE THE PART(S) NUMBER(S) TO ARTHREX. **ADDITIONAL INFORMATION OBTAINED 2/10/2017; PATIENT PROVIDED HOSPITAL RECORDS WHICH DESCRIBED THE IMPLANTS SHE RECEIVED. BASED ON THE DESCRIPTION IT WAS DETERMINED THE FOLLOWING ARE THE IMPLANTS: AR-502-1L ((B)(4)) AND AR-504-PSB8 ((B)(4)). MATERIAL COMPOSITION HAS BEEN PROVIDED TO THE PATIENT. **ADDITIONAL INFORMATION OBTAINED 2/13/2017: PATIENT REPORTS SHE HAS BEEN HAVING ISSUES SINCE HER ORIGINAL PARTIAL KNEE SURGERY TOOK PLACE ON (B)(6) 2016. PATIENT REPORTS ONGOING PAIN, SWELLING, LIMITED RANGE OF MOTION (UNABLE TO FULLY EXTEND), AND UNABLE TO FULLY WEIGHT BEAR (STILL USING CANE AND CRUTCHES). PATIENT STATES HER SURGEON HAS DONE META

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Hypersensitivity/Allergic reaction; Joint Swelling; Loss of Range of Motion; Pain

  MAUDE report 6574807 ↗