Arthrex® AR-9501-07CPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867061019), received between Dec 14, 2016 and Oct 28, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Fitting Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem

  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: Metal Related Pathology; Skin Discoloration

  MAUDE report 10746436 ↗
• InjuryFeb 25, 2020Improper or Incorrect Procedure or Method; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT ON OR ABOUT (B)(6) 2017 THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY SURGERY. IT WAS REPORTED THAT THE OPERATION REQUIRED IMPLANTATION OF A SPECIFIC MILLIMETER-SIZED POLYETHYLENE LINER AND THE WRONG SIZED LINER WAS PROVIDED TO THE SURGEON. IT WAS FURTHER REPORTED THAT THE HARDWARE IMPLANTED DID NOT MATCH THE TRIAL COMPONENTS THE SURGEON HAD SELECTED FOR THE PATIENT AND IMPROPER PROSTHETIC COMPONENTS WERE IMPLANTED CAUSING THE NEED FOR SUBSEQUENT SURGICAL TREATMENT. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE INITIAL (B)(6) 2017 PROCEDURE: AR-9503S-03, UNIVERS REVERSHUMERAL INSERT SMALL/36/+3, LOT 170052310, AR-9502F-36CPC, UNIVERS REVER SUTURE CUP, 39(NEUTRAL) (LOT 160117904 OR LOT 170039706 - SPECIFIC LOT UNKNOWN), AR-9501-07CPC, UNIVERS REVERS STEM, SIZE 7, LOT 170035214, AR-9504M-04, UNIVERS REVERS GLENOSPHERE 39 +4 LAT, LOT 160123713, AR-9165-20NL, CENTRAL SCREW, NON-LOCKING, UNI REV, 6.5 X 20MM, LOT 10070240, AR-9145-30, UNI GLENOID-PERIPHERAL LOCKING SCREW, LOT 17009612, AR-9145-24, UNI GLENOID-PERIPHERAL LOCKING SCREW, LOT 160115411, AR-9120-02, UNIVERSAL GLENOID BASEPLATE MEDIUM, LOT 2501470208. ADDITIONAL INFO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9751212 ↗
• InjuryDec 14, 2016Fitting Problem

  IT WAS REPORTED THAT CUP AR-9502-39RCPC, LOT 150006510, LINE 176623 COULD NOT BE MOUNTED ON SHAFT AR-9501-07PC, LOT 150023110, LINE 176338. SCREW COULD BE SCREWED IN, HOWEVER, CUP DID NOT FIT INTO THE NUT ON THE TOP OF THE SHAFT. SURGEON OPENED TWO ADDITIONAL CUPS TO USE THE SCREWS TO TRY TO FIX THE CUP TO THE SHAFT, HOWEVER, WITHOUT SUCCESS. SURGEON TRIED SEVERAL CUPS AND WAS FINALLY ABLE TO CONNECT AN AR-9502-39CPC CUP ON A AR-9501-08CPC SHAFT. SURGEON HAD TO DO A PARTIAL RESECTION AT THE HUMERUS WITH A RASP TO MAKE COMPONENTS FIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6173251 ↗