Arthrex® AR-9100-10SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867134607), received between Oct 25, 2018 and Jun 6, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Separation” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2022Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2020 . IN (B)(6) 2021, PATIENT COMPLAINED OF PAIN. ON (B)(6) 2022, PATIENT WAS POSITIVE FOR A C. ACNES INFECTION AND UNDERWENT REVISION SURGERY ON (B)(6) 2022. DURING THE REVISION ARTHROPLASTY SURGERY, AN AR-9106-02 ARTHREX UNIVERS VAULTLOCK GLENOID, AN AR-9100-10S UNIVERS APEX HUMERAL STEM, AND AN AR-9148-19P ARTHREX UNIVERS II 3D HUMERAL HEAD WERE EXPLANTED. CASE WAS COMPLETED BY IMPLANTING AN ANTIBIOTIC CEMENT SPACER. THE ORIGINAL SHOULDER ARTHROPLASTY PROCEDURE, WAS PERFORMED AT FOX VALLEY ORTHOPEDIC ASSOCIATES SURGERY CENTER BY A DIFFERENT SURGEON. ADDITIONAL INFORMATION RECEIVED ON 5/18/2022: ALL DEVICES THAT WERE IMPLANTED ON (B)(6) 2020 WERE EXPLANTED DURING REVISION SURGERY ON (B)(6) 2022. AFTER PATIENT COMPLAINT OF PAIN IN (B)(6) OF 2021, PATIENT WAS MONITORED AND REVISION SURGERY WAS SCHEDULE. DUE TO OTHER NON-ORTHOPEDIC REASONS, REVISION SURGERY WAS DELAYED UNTIL (B)(6) 2022. OTHER THAN THE ANTIBIOTIC CEMENT SPACER, NO NEW ARTHREX DEVICES WERE IMPLANTED DURING REVISION SURGERY.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14601955 ↗
• InjuryDec 27, 2021Failure to Osseointegrate

  ON (B)(6) 2021, IT WAS REPORTED BY A SALE REPRESENTATIVE VIA THE PHONE THAT AR-9100-10S, AR-9146-18P AND AR-9105-03 WERE EXPLANTED (B)(6) 2021 DUE TO PAIN AND ROTATOR CUFF FAILURE CONFIRMED BY IMAGING. THESE DEVICES WERE IMPLANTED ON (B)(6) 2015 @ (B)(6) HOSPITAL. THE CASE WAS COMPLETED USING A COMPETITORS REVERSE TOTAL SHOULDER SYSTEM.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13087669 ↗
• InjuryDec 21, 2021Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TSA PROCEDURE ON (B)(6) 2019 WHERE AN ARTHREX BALL AND SOCKET (PNS UNKNOWN, PENDING OPERATIVE REPORT) WERE IMPLANTED INTO THE PATIENT¿S RIGHT SHOULDER. DURING THE PATIENT¿S FOLLOW UP APPOINTMENT, THE PATIENT COMPLAINED OF PAIN IN HIS RIGHT SHOULDER AND AN X-RAY WAS TAKEN. ACCORDING TO THE SURGEON, THERE WAS NOTHING SHOWING ON THE X-RAY THAT WAS UNUSUAL. THE SURGEON SUGGESTED THE PAIN WAS DUE TO INTERNAL SUTURES IN THE PATIENT¿S BICEP BUT NO FURTHER MEDICAL TREATMENT WAS PERFORMED. THE PATIENT OPTED TO SEE A DIFFERENT SURGEON FOR THE PAIN AND IN (B)(6) 2021 (EXACT DATE UNKNOWN, PENDING OPERATIVE REPORT), A LAPAROSCOPIC PROCEDURE WAS PERFORMED FOR AN INTERNAL VISUAL. ONCE INSIDE THE JOINT, THE SURGEON FOUND THAT THE SOCKET HAD EXPLODED. HE BROKE DOWN THE FRAGMENTS AND REMOVED THE FRAGMENTS AND CEMENT FROM THE TSA PROCEDURE ARTHROSCOPICALLY¿NO DEVICES WERE IMPLANTED DURING THIS PROCEDURE. TO DATE, THE PATIENT IS STILL EXPERIENCING PAIN IN THE RIGHT SHOULDER AS IT IS NOW BALL ON BONE AND ALSO HAS A DECREASE IN ROM. THE PATIENT HAS SEEN A THIRD SURGEON WHO HAS SUGGESTED AN RTSA, HOWEVER, NO PROCEDURE HAS BEEN SCHEDULED. ADDITIONAL INFORMATION

  Patient problems: Failure of Implant; Foreign Body In Patient; Implant Pain; Laceration(s); Loss of Range of Motion

  MAUDE report 13054501 ↗
• InjuryJan 2, 2019Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2017 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-9100-10S LOT: 10055062; AR-9106-01 LOT: 1027261611 AND AR-9146-20P LOT: 160051618. ON (B)(6) 2017, THE PATIENT UNDERWENT A REVISION TSA/GLENOID REVISION AND HUMERAL HEAD SIZE REDUCTION (CAPTURED ON CASE (B)(4)) FOR AN UNKNOWN REASON AND THE FOLLOWING DEVICES WERE EXPLANTED: AR-9106-01 LOT: 1027261611 (MEDWATCH 1220246-2019-00828) AND AR-9146-20P LOT: 160051618 (MEDWATCH 1220246-2019-00829) AND REPLACED WITH: AR-9105-01 LOT: 113601629 AND AR-9144-19P LOT: 160047318. THE PATIENT THEN UNDERWENT A SECOND REVISION TSA ON (B)(6) 2018. UPON ENTERING THE JOINT SPACE, THE SURGEON REALIZED THE HEAD WAS BARELY ASSOCIATED TO THE "TRUNION". MOREOVER, THE "TRUNION" WAS DISASSOCIATED FROM THE STEM AS WELL AND THE SUPERIOR VERSION SCREW WAS BACKED ALL THE WAY OUT. ESSENTIALLY THE STEM FELL APART INTO 4 PIECES: THE SCREW, THE HEAD, THE STEM, AND THE "TRUNION". THE FOLLOWING DEVICES WERE EXPLANTED AND REPLACED WITH A SYSTEM FROM ANOTHER MANUFACTURER: AR-9100-10S LOT: 10055062 (IMPLANTED DURING (B)(6) 2017 ORIGINAL PROCEDURE); AR-9105-01 LOT: 113601629 (IMPLANTED

  Patient problems: Foreign Body In Patient

  MAUDE report 8209505 ↗
• InjuryOct 25, 2018Break; Material Separation

  IT WAS REPORTED THAT DURING A REVISION OF HEMI TSA TO REVERS TSA PROCEDURE, THE KNOB ON THE SLAP HAMMER, AR-9202-14, BROKE OFF ON THE FOURTH ATTEMPT FOLLOWING THE EXTRACTION PROCEDURE STEPS. THE BROKEN PIECE WAS DISCARDED. THE SURGEON USED A BONE HOOK RETRACTOR (NON-ARTHREX) AND A SLOTTED MALLET, AR-9231-21, FROM THE BONE PREP TRAY TO COMPLETE THE EXTRACTION. THE INSTRUMENT BROKE CLEANLY INTO TWO PIECES. ADDITIONAL INFORMATION PROVIDED 9/19/2018: THIS WAS A REVISION FROM A HEMI ARTHROPLASTY WITH AN ARTHREX APEX STEM AND HARDWARE. NO GLENOID IMPLANTS. THE SURGERY WAS PERFORMED BECAUSE THE PATIENT FELL AND TORE HER ROTATOR CUFF A FEW MONTHS AGO. THE SURGEON FELT THAT A REVERSE TOTAL SHOULDER ARTHROPLASTY WOULD HAVE THE BEST OUTCOME FOR THE PATIENT. ZIMMER IMPLANTS WERE USED FOR THE REVERSE PROCEDURE. ADDITIONAL INFORMATION PROVIDED 10/2/2018: THE ORIGINAL DOS WAS (B)(6) 2017. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE ORIGINAL SURGERY AND EXPLANTED DURING THE REVISION: APEX HUMERAL STEM: AR-9100-10S/10128790. HUMERAL HEAD: AR-9146-18P/140107415.

  Patient problems: Fall; Injury

  MAUDE report 8006632 ↗