Arthrex® AR-9120-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867057340), received between Sep 19, 2017 and Feb 26, 2024 — classified as 15 injuries.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 26, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A REVISION OF AN ECLIPSE WITH UNIVERSAL GLENOID WAS NECESSARY DUE TO WEAR OF THE POLYETHYLENE GLENOID OF THE UNIVERSAL GLENOID BASE PLATE. IT WAS FURTHER REPORTED THAT THE ISSUE CAUSE A STRONG METALLOSIS DUE TO THE METAL TO METAL FRICTION. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION SURGERY: CD-9341-16 ECLIPSE HEAD, SIZE 41/16 TINBN COATED AR-9300-41CPC ECLIPSE TRUNION,41 MM TPS CTD AR-9301-02 ECLIPSE CAGE SCREW M, 35MM AR-9120-01 UNIVERSAL GLENOID - BASEPLATE SMALL AR-9165-20 UNIVERSAL GLENOID - CENTRAL SCREW 20MM 2X UNKNOWN PERIPHERAL SCREWS

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18776970 ↗
• InjuryOct 24, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A LOOSENING OF THE ECLIPSE PROSTHESIS LED TO REVISION TO UNIVERS REVERS. THE FOLLOWING DEVICES WERE INITIALLY IMPLANTED: ECLIPSE HEAD, ECLIPSE TRUNION, ECLIPSE CAGE SCREW AND UNIVERSAL GLENOID INLAY. THE UNIVERSAL GLENOID HAD A GOOD ANCHORAGE, SO THE PE WAS REMOVED AND A GLENOSPHERE WAS INSTALLED. ON THE HUMERAL SIDE AN ECLIPSE REMOVED AND UNIVERS REVERS INSTALLED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE (B)(6) 2023. FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON THE (B)(6) 2017 AND THE FOLLOWING DEVICES WERE IMPLANTED: AR-9145-30 LOT: 160058310, AR-9165-15 LOT: 160064010, AR-9120-01 LOT: 160061912, AR-9145-36 LOT: 160058410, AR-9121-01 LOT: 160101410, AR-9300-41CPC LOT: UNK.

  Patient problems: Failure of Implant

  MAUDE report 17994957 ↗
• InjuryFeb 7, 2022Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A REVISION SURGERY IS REQUIRED DUE TO A COMPLICATION AND A LOOSENING OF AN ARTHROPLASTY IMPLANT. THE DATE OF THE PRIMARY PROCEDURE WAS ON (B)(6) 2017 FOR A REVERSE TOTAL SHOULDER REPLACEMENT WERE A UNIVERS REVERS, GLENOSPHERE SIZE (39MM), GLENOSPHERE OFFSET (4MM LATERAL), STEM FIXATION (PRESSFIT), STEM SIZE (6), AND SUTURECUP (2MM POSTERIOR) WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 1/20/2022: THE COMPLICATION WAS REPORTED ON JULY 11, 2018. THE DATE OF THE REVISION PROCEDURE WAS (B)(6) 2018 FOR A RSA WITH CANCELLOUS ALLOGRAFT AND AN AR-9120-01 AND AN AR-9503M-06 WAS EXPLANTED. DEVICE(S) WERE DISCARDED.

  Patient problems: Insufficient Information

  MAUDE report 13471327 ↗
• InjuryDec 21, 2020Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT HAD A REVERSE SHOULDER REPLACEMENT PERFORMED ON (B)(6) 2015. THE PERIPHERAL SCREWS ON THE BASEPLATE HAD BROKEN REQUIRING THE PATIENT TO HAVE A REVISION SURGERY (B)(6) 2020 AT A DIFFERENT FACILITY. THE GLENOID COMPONENTS WERE REVISED AND THE IMPLANT WAS REPLACED WITH AN MGS GLENOID BASEPLATE. EXPLANTED DEVICES WERE DISCARDED BY THE FACILITY AT TIME OF PROCEDURE. THE FOLLOWING ORIGINAL IMPLANTS WERE EXPLANTED: AR-9120-01 GLENOID BASEPLATE LOT 140122110, AR-9145-30 UNI GLENOID PERIPHERAL LOCKING SCREW LOT 150018908, AR-9145-24 UNI GLENOID PERIPHERAL LOCKING SCREW LOT 140123008. ADDITIONAL INFORMATION OBTAINED 12/1/20: THE PATIENT DID NOT SUFFER ANY TRAUMA OR FALL PRIOR TO THE REVISION. THE SURGEON NOTED THE PATIENT WAS AN ACTIVE GOLFER AND TENNIS PLAYER.

  Patient problems: Failure of Implant

  MAUDE report 11046491 ↗
• InjuryNov 23, 2020Break

  IT WAS REPORTED THAT DURING A (B)(6) 2020 REVISION REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE THE FOLLOWING ISSUES OCCURRED WITH TWO ARTHREX INSTRUMENTS: INSTRUMENT 1: THE MEDIUM T-15 DRIVER (AR-9545-T15-02 #8001928) HAS BEEN COMPROMISED. WHEN TRYING TO EXTRACT THE CENTRAL SCREW FROM A UNIVERSAL GLENOID, THE TIP OF THE DRIVER BECAME TWISTED AND A SMALL PIECE BROKE OFF INTO THE HEAD OF THE CENTRAL SCREW. THERE WAS A 5 MINUTE DELAY IN SURGERY AS THE SCREW HEAD COULD NO LONGER BE ACCESSED. THE SURGEON USED OSTEOTOMES AROUND THE PERIPHERY OF THE BASEPLATE TO EVENTUALLY EXTRACT THE BASEPLATE AND CENTRAL SCREW AS ONE PIECE. THE INSTRUMENT BROKE INTO TWO PIECES. BOTH PIECES WERE RECOVERED, BUT THE SMALLER PIECE WAS LODGED INTO THE CENTRAL SCREW IMPLANT WHICH WAS NOT AVAILABLE FOR RETURN. THERE WAS NO UNPLANNED INCISION. A SECOND SURGERY IS NOT NECESSARY. DEVICE WILL BE RETURNING FOR EVALUATION. THE EVENT DID NOT OCCUR DURING THE INITIAL USE OF THE DEVICE. INSTRUMENT 2: THE TRINITY BASEPLATE IMPACTOR (AR-9165CDG #(10)051917) HAS BEEN COMPROMISED. THE SURGEON ENGAGED THE ALREADY IMPLANTED BASEPLATE WITH THE IMPACTOR SO THAT IMPACTION MIGHT DISRUPT THE BONY BOND WITH THE BASEPLATE. AFTER

  Patient problems: Foreign Body In Patient

  MAUDE report 10884248 ↗
• 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 10746372 ↗
• InjurySep 2, 2020Break; Corroded; Unstable; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE AN INITIAL REVISION SURGERY ON (B)(6) 2018 DURING WHICH THE FOLLOWING DEVICES WERE IMPLANTED: AR-9120-01 (LOT 170115215), AR-9145-36 (LOT 170037012), AR-9145-30 (LOT 170057712), AR-9504S-04 (LOT 170091414), AR-9555-09 (LOT 2501367202), AR-9503S-03C (LOT 2501374603), AR-9165-25 (LOT 2501357504). THE (B)(6) 2018 PROCEDURE WAS A REVISION OF ARTHREX PRODUCTS BECAUSE THE PATIENT HAD GLENOID INSTABILITY DUE TO BASEPLATE PLACEMENT ON THE PRIMARY. IT IS UNKNOWN IF THE 2018 REVISION WAS EVER REPORTED TO ARTHREX AS NO DETAILS FROM THE ORIGINAL SURGERY ARE KNOWN TO SEARCH/MATCH PART NUMBERS. THE IMPLANTS PUT IN ON (B)(6) 2018 WERE DONE SO IN A COMPROMISED GLENOID WITH POOR BONE QUALITY. THE PERIPHERAL SCREWS BROKE AND LED TO BASEPLATE FAILURE. THE GLENOSPHERE REMAINED ENGAGED IN THE BASEPLATE. THERE WAS SIGNIFICANT CORROSION OF THE HUMERAL POLY INSERT. THE GLENOID COMPONENTS FAILED NEARLY TWO YEARS AGO BUT THE PATIENT WAITED UNTIL (B)(6) 2020 TO HAVE A REVISION SURGERY. THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON ATTRIBUTED THE FAILURE TO PUTTING THE BASEPLATE ON HER ORIGINAL REVERSE PROCEDURE TOO SUPERIOR ON THE FACE OF THE GLENOID WITH S

  Patient problems: No Code Available

  MAUDE report 10482711 ↗
• InjuryJun 16, 2020Malposition of Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SURGEON HAS STATED THAT THE POSITION OF THE IMPLANTED BASE PLATE IS NOT IN A PROPER POSITION AND THEREFORE THE SURGEON DECIDED TO PERFORM A REVISION SURGERY. DURING THE REVISION SURGERY THE SURGEON DECIDED TO MAKE AN EASIER ACCESS TO THE GLENOID TO REPLACE THE WHOLE PROSTHESES. IT WAS FURTHER REPORTED THAT IT WAS FOUND ON THE X-RAY THAT DUE TO THE POSITION OF THE BASE PLATE A SCAPULAR NOTCHING WAS CAUSED. THE FOLLOWING IMPLANTS WERE EXPLANTED: BASE PLATE AR-9500-01 (PART NUMBER UNKNOWN AS THE PROVIDED ONE IS INCORRECT), GLENOSPHERE AR-9504S-04, STOCK AR-9501-08CPC, 2X PERIPHERE SCREWS (LOCKING) (PART NUMBER UNKNOWN), CENTRAL SCREWS (LOCKING) (PART NUMBER UNKNOWN), PE-INLAY (PART NUMBER UNKNOWN). UPDATE 07-JUN-2020: FURTHER INFORMATION WERE PROVIDED THAT THE BASE PLATE WAS NOT OPTIMALLY PLACED AND THE PLATE DID NOT SINK. DURING THE SURGERY IT WAS ALSO DISCOVERED THAT THE PLATE HAD GOOD OSSEOINTEGRATION. THE SIZE THE CENTRAL SCREW IS AN AR-9165-15.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10158180 ↗
• InjuryApr 22, 2020Break

  IT WAS REPORTED THAT ON (B)(6) 2019 A REVERS SHOULDER ARTHROPLASTY WAS PERFORMED. EVERYTHING WENT WELL AND IT WAS FINISHED SUCCESSFULLY. THE SURGEON WAS SATISFIED AFTER THE CASE. THIS WAS ALSO SHOWED ON THE X-RAYS. APPROXIMATELY 6 MONTHS POST-OP THE PATIENT REPORTED SUBSEQUENTLY FAILING WHILE PUTTING ON TROUSERS. HE FELT AN ISSUE. THIS WAS WHEN THE GLENOID SIDE GAVE WAY. IT WAS AN ELECTIVE REVERS AND NOT A FRACTURE REVERS. X-RAYS WERE DONE ON (B)(6) 2020. A REVISION SURGERY IS PLANNED TO BE ON (B)(6) 2020. UPDATE 02-APR-2020: FURTHER INFORMATION WAS RECEIVED: THE REVISION SURGERY WENT AHEAD ON (B)(6) 2020 AFTERNOON. IT WAS REVISED WITH THE NEW MODULAR GLENOID SYSTEM, SUCCESSFULLY USING AN ILIAC CREST GRAFT. EVERYTHING WENT VERY WELL. THE FAILED DEVICES WERE RETRIEVED, HOWEVER BOTH PERIPHERAL SCREWS WERE BROKEN AND THE TIPS REMAIN IN THE PATIENT. BASEPLATE, CENTRAL SCREW & REMAINING PORTION OF PERIPHERAL SCREWS X 2 WILL BE RETURNED ASSEMBLED. ALSO FROM THE HUMERAL SIDE THE CUP AND LINER, WHICH NEEDED TO BE REMOVED FOR ACCESS, WILL BE RETURNED. THERE WAS NO ISSUE WITH THE HUMERAL SIDE, HOWEVER THEY WILL BE RETURNED REGARDLESS.

  Patient problems: Device Embedded In Tissue or Plaque; Fall

  MAUDE report 9985350 ↗
• InjuryFeb 3, 2020Device Slipped

  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 SURGEON 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 O

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9659037 ↗
• 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. THE REVISION SURGERY IS BEING REPORTED UNDER CASE (B)(4). PATIENT HAS RECENTLY BEEN ADMITTED TO THE HOSPITAL DUE TO A SHOULDER INFECTION. THE INFECTION IS BEING REPORTED UNDER THE FOLLOWING: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 8483585 ↗
• InjuryMar 21, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TSA PROCEDURE ON (B)(6) 2018. 9 MONTHS POST-OP, ON (B)(6) 2019, THE PATIENT WAS SEEN BY THEIR SURGEON FOR A FOLLOW-UP VISIT WHERE AN X-RAY WAS TAKEN TO DETERMINE PROGRESS. THE X-RAY SHOWED THAT THE BASEPLATE AND GLENOSPHERE WERE DISLOCATED. THE PATIENT STATED THAT NO TRAUMA HAD OCCURRED. A COPY OF THE X-RAY IS UNABLE TO BE OBTAINED. A REVISION SURGERY TOOK PLACE ON (B)(6) 2019 AND THE FOLLOWING DEVICES WERE ALL EXPLANTED: AR-9145-30 / LOT: 170156313, AR-9145-36 / LOT: 170139313, AR-9504M / LOT: 140119609, AR-9503M-06 / LOT: 160010109, AR-9120-01 / LOT: 170145515, AND AR-9165-20 / LOT: 150008108. THE SURGEON SWITCHED TO AN RTSA AND IMPLANTED THE FOLLOWING: AR-9502-39ARCA / LOT: 261519 AND AR-9550-19RCA / LOT: 10031668. ADDITIONAL INFORMATION PROVIDED 3/29/2019: THE AR-9145-30 SCREW BROKE UPON REMOVAL OF HARDWARE. TIP WAS RETRIEVED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8440405 ↗
• InjurySep 24, 2018Insufficient Device Problem Information

  IT WAS REPORTED BY A NURSE AT AN ALLERGIST'S OFFICE THAT A PATIENT HAD RIGHT SHOULDER-REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2017. DURING THE SURGERY THE FOLLOWING PRODUCTS (LOT NUMBERS UNKNOWN) WERE IMPLANTED IN THE PATIENT: AR-9501-06P UNIVERSAL REVERSE HUMERAL STEM, AR-9502-36RCPC UNIVERSAL REVERSE CUP, AR-9145-30 UNIVERSAL GLENOID PERIPHERAL LOCKING SCREW (QTY UNKNOWN), AND AR-9120-01 UNIVERSAL GLENOID BASEPLATE SMALL. IT HAS BEEN REPORTED THAT PATIENT BEGAN HAVING REACTION TYPE SYMPTOMS, LOW GRADE TEMPERATURE - PAIN - RASH, ALMOST IMMEDIATELY AFTER THE PROCEDURE WHICH HAS PERSISTED. NO CULTURES HAVE BEEN TAKEN; HOWEVER BLOOD WORK TAKEN SHOWED NO INFECTION INDICATED. PATIENT IS BEING SEEN BY AN ALLERGIST TO ATTEMPT TO DETERMINE IF PATIENT MAY HAVE AN ALLERGY TO THE ARTHREX IMPLANTS. MATERIAL COMPOSITION OF THE PRODUCTS HAS BEEN PROVIDED TO THE REPORTER.

  Patient problems: Alteration In Body Temperature; Pain; Rash; Reaction

  MAUDE report 7901952 ↗
• InjuryDec 21, 2017Break; Loose or Intermittent Connection; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE UNIVERSAL GLENOID GOT LOOSE AND BOTH PERIPHERAL SCREWS BROKE. NO BONY INGROWTH IN BASEPLATE. PATIENT DID NOT SUFFER ANY INJURY/ FALL POST SURGERY BUT PATIENT WAS NON-COMPLIANT WITH REGARDS TO POST-OP REHAB SCHEDULE. HE IS A HAND LABOURER, WORKING ON TRUCKS. THIS WAS A THIRD SURGERY. THE IMPLANTS WERE REMOVED, APART FROM THE BROKEN-OFF SUPERIOR SCREW, WHICH COULD NOT BE RETRIEVED. AS THIS PART WAS DEEP IN THE BONE, IT WILL NOT INTERFERE WITH THE HUMERAL IMPLANT. AFTER REMOVAL OF THE IMPLANTS, ALL REMAINING HOLES IN THE GLENOID WERE BONE GRAFTED, THUS CONVERTING A TOTAL SHOULDER PROSTHESIS TO A HEMI. MALE, AGE (B)(6), WEIGHT EST. (B)(6) KG. THE UHMWPE INLAY (B)(4) HOWEVER WAS HEAVILY DAMAGED DURING THE ATTEMPT TO RETRIEVE THE PART DURING THE REVISION. IT LOOKED INTACT BEFORE THE SURGEON STARTED THE RETRIEVAL. WHEN RETRIEVED, THE BASEPLATE DIDN'T HAVE ANY BONY INGROWTH, SO NO BONE WAS CLEANED OFF THE IMPLANT. THE IMPLANT CAME OUT TOGETHER WITH THE REMAINING WELL FIXED SCREWS. THE SURGEON STATED THAT THE PATIENT WAS NON-COMPLIANT WITH REGARDS TO HIS POST-OP REHAB SCHEDULED AND STARTED WORKING TOO SOON AFTER FIRST AND SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 7137339 ↗
• InjurySep 19, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD REVERSE TOTAL SHOULDER ON (B)(6) 2016. THE PATIENT SUPPOSEDLY FELL IN (B)(6) WHICH DISLODGED THE BASEPLATE/GLENOSPHERE. REVISION SURGERY WAS COMPLETED ON (B)(6) 2017, CONVERTING TO HEMI. **ADDITIONAL INFORMATION RECEIVED ON 9/5/2017: THE DEVICES EXPLANTED DURING REVISION: AR-9120-01 LOT 160012712 (LINE 204892), AR-9165-15NL LOT 1444855 (LINE 205048), AR-9145-30 LOT 160024110 (LINE 205049), AR-9504S-04 LOT 160036711 (LINE 205050), AR-9503S-06 LOT 160010209 (LINE 205051), AR-9145-30 LOT 160009610 (LINE 205056). THE DEVICES IMPLANTED DURING THE REVISION WERE AR-9950-19RCA AND AR-9502-36ARCA. QUALITY OF BONE WAS REPORTED TO BE POOR. MALE, (B)(6).

  Patient problems: Fall

  MAUDE report 6876269 ↗