Arthrex® AR-9502-36CPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867061125), received between Dec 4, 2018 and Oct 28, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryOct 28, 2020Patient-Device Incompatibility

  IT WAS REPORTED THAT DUE TO A METALLOSIS THE SHOULDER AND THE ARM OF THE PATIENT TURNED BLACK. THE SURGERY WHICH LED TO THE REPORTED EVENT WAS A SHOULDER PROSTHESIS WHICH WAS PERFORMED ON THE (B)(6) 2015. ACCORDING TO THE CUSTOMER ARTHREX DEVICES WERE IMPLANTED DURING THE INITIAL SURGERY IN 2015. CURRENTLY IT IS NOT KNOWN IN WHICH HOSPITAL THE INITIAL SURGERY TOOK PLACE. THEREFORE NO FURTHER INFORMATION ABOUT THE DETAILED INCIDENT AND THE USED ARTHREX PART NUMBERS ARE CURRENTLY AVAILABLE. UPDATE 12-OCT-2020: INITIALLY THE LOT NUMBERS WHICH WERE AFFECTED WERE NOT PROVIDED HOWEVER FURTHER INFORMATION WERE NOW PROVIDED THAT THE FOLLOWING PARTS WERE USED DURING THE INITIAL SURGERY 2015: AR-9120-01, LOT: 140113110. AR-9145-30, LOT: 140123108. AR-9504S-04, LOT: 2501212801. AR 9165-15, LOT: 140103207. AR-9145-30, LOT: 2501417704. AR-9502-36CPC, LOT: 140120310. AR -9501-07CPC, LOT: 2501215303. AR-9503S-03 , LOT: 140104307. AR-9555-15, LOT:2501215101. AR-7213, LOT: 12812. AR-7200, LOT: 12795. HOWEVER IT COULD NOT BE CONFIRMED WHICH DEVICE HAS LED TO THE REPORTED ISSUE AND IF THE DEVICES ARE AVAILABLE FOR EVALUATION.

  Patient problems: Skin Discoloration; Toxicity

  MAUDE report 10746434 ↗
• InjuryDec 4, 2018Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED BY THE SALES REP THAT THERE WAS A REVISION OF A RIGHT TOTAL SHOULDER CASE ON (B)(6) 2018. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2015. THE REVISION WAS DUE TO LIMITED RANGE OF MOTION AND PAIN. SEVEN DEVICES WERE REMOVED FROM THE PATIENT; THERE WAS PROXIMAL METALLOSIS IN THE SHOULDER JOINT AND THE GLENOSPHERE HAD DISASSOCIATED FROM THE BASEPLATE. THE FOLLOWING ARTHREX REPLACEMENT DEVICES WERE IMPLANTED: AR-9504L-04, UNIVERS REVERSE GLENOSPHERE, LOT 170142415; AR-9502F-42CPC, UNIVERS REVERSE SUTURECUP, LOT 170117105; AND AR-9503L-06, UNIVERS REVERSE HUMERAL INSERT, LOT 170170513. ADDITIONAL INFORMATION OBTAINED 11/8/2018: SALES REP HAS CONFIRMED THAT HIS ORIGINAL REPORT STATING 7 DEVICES WERE EXPLANTED WAS INCORRECT. ONLY THE FOLLOWING THREE DEVICES WERE EXPLANTED: AR-9503S-06 HUMERAL INSERT (LOT 2601221201), AR-9502-36CPC CUP (LOT 2501407907) AND AR-9504S-04 GLENOSPHERE (LOT 2501346003). ALL THREE DEVICES ARE BEING RETURNED TO ARTHREX FOR EVALUATION. ACCORDING TO THE MEDICAL RECORDS DURING THE REVISION SURGERY, THE SURGEON DISCOVERED THE GLENOSPHERE TO BE COMPLETELY DISASSOCIATED FROM THE BASEPLATE. THE SURGEON ALSO NOTED A SIGNIFICANT AMOUNT OF WEAR ON THE INFERIOR

  Patient problems: Loss of Range of Motion; No Code Available; Pain; Toxicity

  MAUDE report 8129865 ↗