Arthrex® AR-9503S-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867061293), received between Dec 7, 2016 and Dec 23, 2025 — classified as 11 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem

  ON 12/04/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT WHEN AN AR-9503S-03 HUMERAL INSERT HIT THE CUP, IT GOT DAMAGED AND WOULD NOT HOOK INTO THE CUP. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881605 ↗
• InjuryMar 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/8/2025, A CLINDEX NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY SUFFERED A SUBLUXATION, WHICH RESULTED IN A REVISION OF THE COMPONENTS ON (B)(6) 2023. THE EVENT WAS INDICATED AS UNRELATED TO THE UNIVERS REVERS APEX SYSTEM IMPLANTED ON (B)(6) 2023. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 2/25/2025 VIA CLINDEX NOTIFICATION: ON (B)(6) 2023, THE PATIENT REPORTED INSTABILITY, PAIN, AND WEAKNESS. ON (B)(6) 2024, THE PATIENT RETURNED AND REPORTED DIFFICULTY WITH RAISING THE ARM ALONG WITH CONTINUED INSTABILITY, PAIN, AND WEAKNESS. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON 3/7/2025. DURING THE REVISION SURGERY ON (B)(6) 2024, AN AR-9564-2436-LAT ARTHREX UNIVERS REVERS GLENOSPHERE, AN AR-9580-2420-2 UNIVERS REVERS AUGMENTED BASEPLATE, AN AR-9501-10S UNIVERS REVERS APEX HUMERAL STEM, AND AN AR-9503S-03 ARTHREX UNIVERS REVERS HUMERAL INSERT WERE EXPLANTED. THE CASE WAS COMPLETED USING A NEW GLENOSPHERE, A HUMERAL INSERT, A SPACER, AND A BASEPLATE.

  Patient problems: Pain

  MAUDE report 21664997 ↗
• MalfunctionOct 29, 2024Positioning Failure; Positioning Failure

  ON 10/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-9501-05P UNIVERS REVERS HUMERAL STEM AND TWO AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUPS ENGAGED CORRECTLY, BUT THEY WERE LOOSE, ALONG WITH THE TWO AR-9503S-03 UNIVERS REVERS HUMERAL INSERT IN BETWEEN. THE SURGEON COULD WIGGLE THE IMPLANTS AND MAKE THEM MOVE. THE SCREW OF THE TWO AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUPS WAS NOT ENGAGING WITH BOTH AR-9501-05P UNIVERS REVERS HUMERAL STEM. THE CASE WAS COMPLETED BY OPENING A DIFFERENT AR-9501-05P UNIVERS REVERS HUMERAL STEM, AN AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUP, AND AN AR-9503S-03 UNIVERS REVERS HUMERAL INSERT FROM A DIFFERENT LOT NUMBER. THIS WAS DISCOVERED WHEN PUTTING THE PRODUCTS TOGETHER BEFORE INSERTION IN THE PATIENT DURING A RTSA PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED FIFTEEN MINUTES; HOWEVER, IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 20559490 ↗
• MalfunctionOct 29, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-9501-05P UNIVERS REVERS HUMERAL STEM AND TWO AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUPS ENGAGED CORRECTLY, BUT THEY WERE LOOSE, ALONG WITH THE TWO AR-9503S-03 UNIVERS REVERS HUMERAL INSERT IN BETWEEN. THE SURGEON COULD WIGGLE THE IMPLANTS AND MAKE THEM MOVE. THE SCREW OF THE TWO AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUPS WAS NOT ENGAGING WITH BOTH AR-9501-05P UNIVERS REVERS HUMERAL STEM. THE CASE WAS COMPLETED BY OPENING A DIFFERENT AR-9501-05P UNIVERS REVERS HUMERAL STEM, AN AR-9502F-36CPC ARTHREX UNIVERS REVERS SUTURE CUP, AND AN AR-9503S-03 UNIVERS REVERS HUMERAL INSERT FROM A DIFFERENT LOT NUMBER. THIS WAS DISCOVERED WHEN PUTTING THE PRODUCTS TOGETHER BEFORE INSERTION IN THE PATIENT DURING A RTSA PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED FIFTEEN MINUTES; HOWEVER, IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 20559483 ↗
• MalfunctionJul 25, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 4/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9555-09 UNIVERS REVERS SPACER WAS LOOSE AFTER IMPLANTATION. THE AR-9501-06S UNIVERS REVERS APEX STEM AND AR-9502F-36CPC UNIVERS REVERS SUTURECUP ATTACHED PERFECTLY FINE IN THE ASSEMBLY BLOCK. THE AR-9555-09 UNIVERS REVERS SPACER WAS PLACED IN THE PATIENT, AND THE APPROPRIATE DRIVER WAS USED TO TIGHTEN THE ASSEMBLY SCREW. APPROPRIATE TORQUE WAS APPLIED, AND AN AR-9503S-03 UNIVERS REVERS HUMERAL INSERT WAS IMPACTED. ONCE THE UNIVERS REVERS HUMERAL INSERT WAS IMPACTED, IT WAS OBSERVED THAT THE UNIVERS REVERS SPACER HAD, IN FACT, SOMEHOW REMAINED LOOSE. THE ENTIRE CONSTRUCT NEEDED TO BE REMOVED BECAUSE THE UNIVERS REVERS SPACER COULD NOT BE DISASSOCIATED FROM THE UNIVERS REVERS SUTURECUP. THE SURGERY OUTCOME WAS NOT IMPACTED, AND THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITH REPLACEMENTS WE HAD AVAILABLE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING AN APEX STEM CONSTRUCT PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 4/25/2024: THE CASE WAS DELAYED ONLY BETWEEN TEN TO FIFTEEN MINUTES. ADDITIONAL ANESTHESIA WAS UNNECESSARY, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19829103 ↗
• InjuryApr 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 3/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER 36 CAME LOOSE FROM THE SUTURECUP AND COULD NOT BE SEPARATED. THE TRIAL CA ADAPTER WAS PLACED IN THE SUTURECUP AND THE TRIAL CA HEAD WAS PLACED. AN X-RAY WAS TAKEN, AND IT WAS DETERMINED THAT THE CA HEAD WAS THE APPROPRIATE SIZE. THE TRIALS WERE REMOVED. THE STEM/CUP IMPACTOR HANDLE WAS THREADED INTO THE CA ADAPTER. THE TAB OF THE CA ADAPTER WAS ALIGNED WITH THE LATERAL SLOT OF THE SUTURECUP. THE IMPLANT WAS IMPACTED INTO THE SUTURECUP. THE CA HEAD WAS IMPACTED WITH THE GLENOSPHERE IMPACTOR MAKING SURE THE HOOD OF THE HEAD WAS LATERAL. THE CA ADAPTER CAME LOOSE FROM SUTURECUP. THE SURGEON ASKED FOR A NEW CA ADAPTER AND A CA HEAD AS THEY COULD NOT BE SEPARATED. A SECOND AR-9502-36ARCA UNIVERS REVERS CA HUMERAL HEAD ADAPTER WAS PLACED ON THE IMPACTOR HANDLE AND WAS IMPACTED INTO THE SUTURECUP. THE GLENOSPHERE IMPACTOR WAS USED AS WELL TO SEAT THE ADAPTER INTO THE SUTURECUP BUT WITH LITTLE EFFORT, THE CA ADAPTER COULD BE PULLED FROM THE SUTURECUP. THE SURGEON WAS ABLE TO SEPARATE THE FIRST SET OF IMPLANTS AND TRIED AGAIN TO IMPACT THE CA ADAPTER INTO THE SUTUR

  Patient problems: Failure of Implant

  MAUDE report 19062319 ↗
• InjuryJun 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 5/19/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9501-06P HUMERAL STEM, AN AR-9502F-36CPC SUTURE CUP, AN AR-9503S-03 HUMERAL INSERT, AN AR-9564-2436-LAT GLENOSPHERE, AN AR-9560-24 BASEPLATE, AN AR-9561-35S CENTRAL SCREW, (2) AR-9563-28 PERIPHERAL SCREW, AND (2) AR-9563-20 PERIPHERAL SCREW, WERE EXPLANTED DURING A REVISION SHOULDER ARTHROPLASTY SURGERY ON (B)(6) 2023. ON (B)(6) 2022, THE PATIENT UNDERWENT ORIGINAL SURGERY. THEN ON (B)(6) 2023, THE PATIENT STARTED TO EXPERIENCE PAIN. RADIOGRAPHS APPEARED TO SHOW SOME RADIOLUCENT LINES AROUND THE BASEPLATE. THE PATIENT DID NOT REPORT ANY FALLS OR NOTABLE EVENTS. THE INFECTION TYPE HAS NOT BEEN CONFIRMED. DURING THE REVISION SURGERY, AN AR-9150-21 CA HUMERAL HEAD AND AN AR-9100-05P MONOBLOCK STEM WERE IMPLANTED AS FUNCTIONAL ANTIBIOTIC SPACERS. BOTH PROCEDURES WERE PERFORMED BY THE SAME SURGEON BUT AT DIFFERENT FACILITIES.

  Patient problems: Unspecified Infection

  MAUDE report 17111737 ↗
• InjuryNov 22, 2021Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9564-2436-LAT GLENOSPHERE (LINE #1) AND AN AR-9503S-03 HUMERAL CUP (LINE #2) WERE EXPLANTED ON (B)(6) 2021 DUE TO A DISLOCATION, CAUSED BY A FALL. THE DATE OF THE PRIMARY PROCEDURE WAS ON (B)(6) 2021 AND TOOK PLACE AT (B)(6) REHABILITATION AND ORTHOPEDIC INSTITUTE, ARTHREX ACCOUNT #(B)(6). THE AR-9564-2439-LAT GLENOSHPERE, AR-9503-3639-3C COMBO HUMERAL INSERT, AND AR-9555-09 SPACER, WERE IMPLANTED DURING THE REPORTED REVISION SURGERY. THE AR-9503-3639-6C HUMERAL INSERT WAS IMPLANTED THEN EXPLANTED AS THE DEVICE WAS THE INCORRECT SIZE.

  Patient problems: Fall

  MAUDE report 12853692 ↗
• 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 10746464 ↗
• InjuryOct 23, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A REVERSE TOTAL SHOULDER ARTHROPLASTY, (B)(6) 2018. THE PATIENT WAS EXPERIENCING PAIN WITH SHOULDER PAIN FROM IMPINGEMENT. CT/MRI WERE PERFORMED BY THE ORIGINAL SURGEON AND A DECISION WAS MADE TO PERFORM A REVISION PROCEDURE, (B)(6) 2020. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE AR-9503S-03 (LOT170137113) AND AR-9504S-04 (LOT 170147116). TO COMPLETE THE PROCEDURE THE SURGEON SWAPPED AN INFERIOR GLENOSPHERE AND PUT IN A NEW POLY THE SAME SIZE. THE SAME SURGEON PERFORMED BOTH PROCEDURES. THE SAME ARTHREX SALES REPRESENTATIVE WAS PRESENT FOR BOTH PROCEDURES. PER FACILITY THE DEVICES WILL NOT BE RETURNED.

  Patient problems: Pain

  MAUDE report 10730284 ↗
• InjurySep 16, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT ON (B)(6) 2019 A PATIENT HAD A REVERSE SHOULDER PROCEDURE. ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION SURGERY. THE PATIENT HAD AN AUTOGRAFT TO THE GLENOID ON HER INITIAL SURGERY AND IT DID NOT APPEAR TO HAVE HEALED. THE SALES REPRESENTATIVE WHO WAS PRESENT DURING THE REVISION REPORTS THAT THE SURGEON HAD MENTIONED IN SURGERY THAT HE BELIEVED THAT THE LOCKING MECHANISM ON THE BASEPLATE MAY NOT HAVE BEEN FUNCTIONING APPROPRIATELY (THE SCREW WAS NOT LOCKED IN). DURING THE ORIGINAL PROCEDURE THE FOLLOWING ARTHREX DEVICES HAD BEEN IMPLANTED: AR-9564-2436-LAT, GLENOSPHERE, LOT 18.00689. AR-9503S-03, HUMERAL INSERT, LOT 18.00870. AR-9502F-36CPC, UNIVERS REVERS SUTURE CUP, LOT 170141708. AR-9561-25P, MODULAR CENTRAL POST, LOT 5368. AR-9560-24-2, MODULAR BASEPLATE, LOT 5408. AR-9562-36NL, PERIPHERAL SCREW NON-LOCKING, LOT 2018001207. AR-9563-36, PERIPHERAL SCREW LOCKING, LOT 2018001490. AR-9563-40, PERIPHERAL SCREW LOCKING, LOT 2018001491. AR-9501-12P, UNIVERS REVERS HUMERAL STEM SIZE 12, LOT 170125705. DURING THE REVISION SURGERY ALL OFF THE ABOVE LISTED ORIGINAL IMPLANTS WERE EXPLANTED, EXCEPT FOR THE AR-9501-12P, UNIVERS REVERS HUMERAL STEM SIZE 12, WHICH WAS LE

  Patient problems: Impaired Healing

  MAUDE report 10540372 ↗
• InjuryFeb 3, 2020Fracture

  IT WAS REPORTED THAT A REVISION REVERSE TOTAL SHOULDER TOOK PLACE ON (B)(6) 2020. THE REP REPORTED THE REVISION PROCEDURE WAS DUE TO A DISPLACED GREATER TUBEROSITY FRACTURE THAT NEEDED TO BE RETRIEVED. PRIOR TO THE REVISION PROCEDURE THE PATIENT WAS EXPERIENCING PAIN AND A LACK OF RANGE OF MOTION. THE PATIENT HAD A FOLLOW-UP VISIT WITH THEIR SURGEON. X-RAYS TAKEN DURING THE FOLLOW UP VISIT REVEALED A DISPLACED GREATER TUBEROSITY FRACTURE. THE PRIMARY AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON AND TOOK PLACE AT THE SAME FACILITY. THE REP REPORTED AT THIS TIME THE DATE OF THE PRIMARY SURGERY, AND FULL LIST OF ARTHREX PRODUCT IMPLANTED DURING THE PRIMARY PROCEDURE IS CURRENTLY UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE FOLLOWING ARTHREX PARTS WERE EXPLANTED DURING THE REVISION: AR-9503S-03 / LOT: 19.00085 / QTY.: 1, AR-9564-2436-LAT / LOT: 18.01595 / QTY.: 1, AR-9502F-36CPC / LOT: 18.01518 / QTY.: 1, AR-9501-05P / LOT: 18.00881 / QTY.: 1. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE REVISION: AR-9564-2436 / LOT: 19.00917 / QTY.: 1. THE REP STATED THE HUMERAL COMPONENTS IMPLANTED DURING THE REVISION PROCEDURE WERE FROM A DIFFERENT MANUFACTURER. ADDI

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9659053 ↗
• InjuryFeb 3, 2020Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT WAS ORIGINALLY OPERATED ON USING THE ARTHREX REVERSE SHOULDER ON (B)(6) 2018. THE PATIENT ORIGINALLY HAD A SMALL BASEPLATE, 36 +4 GLENOSPHERE, SIZE 8 STEM, PLUS 6 SPACER, 20 CENTRAL SCREW, 2- 30MM PERIPHERAL SCREWS AND A PLUS 3 POLY INSERT IMPLANTED. IN (B)(6) 2019, THE PATIENT CAME TO THE SURGEON'S OFFICE COMPLAINING OF PAIN AND LACK OF MOTION. THE DECIDED TO REVISE THE PATIENT. THE REVISION PROCEDURE TOOK PLACE ON (B)(6) 2019. THE REP REPORTED DURING THE REVISION PROCEDURE, IT WAS CLEARLY OBVIOUS THAT THE BASEPLATE AND SCREWS HAD PULLED OUT OF THE FACE OF THE GLENOID. THE SURGEON REMOVED THE POLY, SPACER, BASEPLATE, SCREWS AND GLENOSPHERE, AND IMPLANTED AN AUGMENTED EXACTTECH GLENOID IMPLANT AND GLENOSPHERE. ONCE THAT WAS COMPLETED, THE SURGEON IMPLANTED A PLUS 12 ARTHREX SPACER AND A PLUS 3 POLY LINER ONTO THE EXISTING SIZE 8 STEM AND 36 CUP. THE IMPLANTS WENT IN WITHOUT ANY PROBLEM AND THE SURGEON WAS VERY PLEASED WITH THE POST OPERATIVE RESULTS. THE SURGEON CHOSE TO KEEP THE IMPLANTS THAT WERE EXTRACTED AND EXPECTS THE PATIENT TO DO WELL. ADDITIONAL INFORMATION RECEIVED ON 01/06/2020: THE REP REPORTED THEY DO NOT HAVE ACCESS TO THE PART OR LOT NU

  Patient problems: Pain

  MAUDE report 9659051 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A TOTAL REVERSE SHOULDER PROCEDURE ON (B)(6) 2018 DURING WHICH THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED: AR-9502F-36RCPC (LOT 170027905); AR-9502F-36CPC (LOT 170018606); AR-9501-06P (LOT 170088903); AR-9503S-03 (170085610); AR-9504S-INF (LOT 160071710); AR-9120-01 (LOT 170115115); AR-9165-20 (LOT 170056412); AR-9145-24 (LOT 170101712). PATIENT ALSO UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 DURING WHICH THE AR-9503S-03 WAS EXPLANTED AND AN AR-9503S-06 (LOT 170150113)WAS IMPLANTED. THIS REPORT (CASE (B)(4)) IS TO DOCUMENT THE REVISION SURGERY. PATIENT HAS RECENTLY BEEN ADMITTED TO THE HOSPITAL DUE TO A SHOULDER INFECTION WHICH IS BEING REPORTED UNDER THE FOLLOWING COMPLAINT NUMBERS: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8483671 ↗
• InjuryDec 7, 2016Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD A SHOULDER DISLOCATION REPAIR PROCEDURE PERFORMED APPROXIMATELY TWO YEARS PRIOR. ON (B)(6) 2016 THE PATIENT UNDERWENT A HUMERAL INSERT EXCHANGE REVISION PROCEDURE ((B)(4)) DUE TO SEVERAL REPORTED DISLOCATIONS AND THE HUMERAL INSERT (POLY) WAS REPORTED TO HAVE HAD ABNORMAL WEAR. AT THAT TIME AN I&D WAS PERFORMED AND THE ORIGINAL HUMERAL INSERT WAS REMOVED AND EXCHANGED AND A TITANIUM SPACER WAS ALSO IMPLANTED. PATIENT LATER DEVELOPED AN INFECTION AT THE OPERATIVE WOUND AND ON (B)(6) 2016 THE SURGEON PERFORMED ANOTHER I&D AND THE HUMERAL INSERT, AR-9503S-03, LOT 160043709, WAS EXPLANTED AND A NEW AR-9503S-03, LOT 160054509, WAS IMPLANTED. PATIENT WAS TREATED WITH ANTIBIOTICS. THE EXPLANTED DEVICE WAS DISCARDED AT THE TIME OF PROCEDURE.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 6150585 ↗