Tornier HRS ARS655101Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00846832093250), received between Apr 21, 2023 and Aug 4, 2026 — classified as 13 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (11 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Migration

  A revision surgery was performed as a result of implant failure as the set screw backed out, decoupling the proximal body from the humeral stem which caused the patient pain.

  Patient problems: Arthritis; Inadequate Osseointegration; Metal Related Pathology; Nonunion/Delayed-union Bone Fracture; Pain; Perforation; Synovitis

  MAUDE report 50131240 ↗
• InjuryMay 6, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, ONE OF THE SURGEONS RECENTLY HAD A CASE WHERE THE IMPLANT DISSOCIATED INSIDE THE PATIENT SHORTLY AFTER THE SURGERY. THEY PLANNED THE REVISION NEXT WEEK, BUT THE SURGEON WOULD LIKE US TO SEND THE DISSOCIATED IMPLANT OFF FOR TESTING TO CONFIRM IT WASN'T AN ISSUE WITH THE IMPLANT ITSELF. THE SURGEON REQUESTED MORE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25097893 ↗
• InjuryOct 15, 2025Inadequacy of Device Shape and/or Size; Unstable; Inadequacy of Device Shape and/or Size; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RSA REVISION CASE DUE TO RESORPTION/STABILITY ISSUES WITH THEIR REVIVE STEM AND PERFORM REVERSE CONSTRUCT. THE STEM WAS SWAPPED FOR A LARGER CONSTRUCT. THERE WAS NO MECHANICAL FAILURES WITH THEM IMPLANT. THE DOCTOR BLAMED IT ON THE PATIENT CONDITION.

  Patient problems: Joint Laxity

  MAUDE report 23301370 ↗
• InjuryOct 15, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT EIGHT-MONTH POSTOPERATIVE IMAGING REVEALED GAPPING AT THE SURGICAL SITE. THE INITIAL ACCOUNT INDICATED THAT ONLY MODULAR COMPONENTS¿INCLUDING THE POLYETHYLENE INSERT, TRAY, LOCKING CAP, AND ASSEMBLY SCREW¿WERE EXCHANGED UNDER FLUOROSCOPIC GUIDANCE. HOWEVER, THIS WAS LATER CORRECTED TO REFLECT THAT THE ENTIRE HUMERAL CONSTRUCT WAS REMOVED AND REPLACED WITH A 230 MM CONSTRUCT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23300590 ↗
• InjurySep 22, 2025Osseointegration Problem; Osseointegration Problem

  THE DISENGAGEMENT OF ASSEMBLY SCREW WITHIN PROXIMAL AND DISTAL BODY CAUSING THE PROXIMAL PART OF REVIVE STEM TO BECOME UNSTABLE RESULTING IN REVISION SURGERY WAS REPORTED. ALSO, POROUS COATING OF PROXIMAL PART OF STEM HAS ERODED/COME OFF THE STEMS SURFACE. PATIENT HAD SYMPTOMS AND HEARD AN AUDIBLE CLUNK, X RAY OF STEM CONFIRMED ISSUE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23111049 ↗
• InjuryJul 21, 2025Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  PATIENT HAD THE LOCKING CAP AND ASSEMBLY SCREW FROM THE STEM IMPLANT BACK OUT POST-OPERATIVELY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556099 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REVERSE SHOULDER ARTHROPLASTY WAS DONE FOR INFECTION. THE SURGEON MENTIONED ENTEROCOCCI WAS DETECTED. THE IMPLANTS WERE REMOVED AND CEMENT SPACER WAS IMPLANTED. NO PRODUCT FAULT WAS REPORTED.

  Patient problems: Bacterial Infection

  MAUDE report 22153776 ↗
• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT 008-00073 SHOUT - TORNIER SHOULDER OUTCOMES STUDY. SHOULDER PAIN. SUBJECT IS EXPERIENCING DISCOMFORT IN THE SHOULDER. PER CALL WITH SITE ON 31-OCT-2024, VERBALLY REVIEWED ADDITIONAL CLINIC NOTES: ¿ (B)(6) 2023, NO CHANGE RADIOGRAPHICALLY (ONGOING), ¿ (B)(6) 2024 WORSENING PAIN, NO LOOSENING AND NO CHANGE IN ALLOGRAFT, LUCENCY AROUND BASEPLATE, BUT NO SHIFTING OF POSITION (ONGOING)".

  Patient problems: Discomfort; Implant Pain

  MAUDE report 20804610 ↗
• InjuryAug 29, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A REVIVE DEVICE HAD A BROKEN ASSEMBLY SCREW, WHICH REQUIRED A REVISION SURGERY.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 20096858 ↗
• InjuryJun 4, 2024Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "OPERATION DATE (B)(6) 2023. PATIENT USED REVIVE STEM WITH PERFORM REVERSE. REP OF THE CASE AS DEFINITELY SAID THERE WAS A LOCKING CAP USED. THE NURSE STRUGGLING INITIALLY WITH THE CAP AND SURGEON THEMSELVES TIGHTENING THE CAP. THE INITIAL XR THE STEM WAS STANDARD. 3 MONTH POST OP THE WAS A GAP BETWEEN PROXIMAL BODY AND DISTAL STEM (ON X-RAY). FINAL XR 7 MONTHS PO THE STEM IS NOW JOINED AGAIN. WE HAVE INQUIRED WHETHER THE PATIENT IS FEELING THESE SHIFTS AND WHETHER THE SURGEON WOULD LIKE TO GO AHEAD WITH THE REVISION AND ASKED IF THEY WILL CONDUCT MORE XRS UNDER COMPRESSION AND NOT TO SEE IF THE IMPLANT IS SHIFTING. LOCKING CAP WAS ON USAGE."

  Patient problems: Inadequate Osseointegration

  MAUDE report 19464075 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18972528 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REVISION SURGERY WAS CONDUCTED IN RESPONSE TO AN INFECTION. AN UPDATE PROVIDED INDICATES A LACK OF INFORMATION REGARDING THE LOT NUMBERS FOR THE SCREWS USED. HOWEVER, IT WAS MENTIONED THAT THE INFECTION APPEARED TO BE LOCALIZED, AND THE PROCEDURE INVOLVED WASHING OUT AND EXCHANGING PARTS.

  Patient problems: Unspecified Infection

  MAUDE report 18779091 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A LAWSUIT THAT THE PATIENT REPORTED HAVING REFRACTORY PAIN AND DYSFUNCTION OF THE SHOULDER WHICH WAS REFRACTORY TO CONSERVATIVE MEASURES. PREOPERATIVE IMAGING WAS SUGGESTIVE OF LOOSENING OF THE HUMERAL COMPONENT, SPECIFICALLY AT THE JUNCTION OF THE PROXIMAL HUMERAL BODY TO THE HUMERAL STEM AT THE ASSEMBLY SCREW JUNCTION.

  Patient problems: Implant Pain

  MAUDE report 17901182 ↗
• MalfunctionJun 30, 2023Packaging Problem; Inaccurate Information; Packaging Problem; Inaccurate Information

  IT WAS REPORTED THAT THE "REVIVE LOANER IMPLANT BANK HAD A 0 (ZERO) MM ASSEMBLY SCREW "SHORT" INCLUDED. THIS IS NOT PART OF THE STANDARD LOANER BANKS IN CANADA. THIS SCREW IS NOT ABLE TO BE USED AS INDICATED WITH THE OTHER COMPONENTS IN THE LOANER KIT. THE DESCRIPTION OF THE ASSEMBLY SCREW IS VERY SIMILAR TO THE CDN APPROVED SCREW. IT WAS NOT NOTICED BEFORE SURGERY. THIS CAUSED COMPLICATIONS IN THE OR WHICH RESULTED IN A SMALLER AND LONGER HUMERAL STEM NEEDED TO FINISH THE SURGERY FOR THE PATIENT." AT A LATER DATE THE FOLLOWING WAS ADDED: PATIENT¿S HUMERAL CANAL WAS REAMED TO A 13MM X130MM REVIVE STEM. ENDED UP IMPLANTING A 15MMX150MM REVIVE PARTIALLY COATED STEM UNCEMENTED. STEM WAS STABLE UPON IMPLANTATION. PATIENT WILL BE VIEWED IN CLINIC IN 21 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240888 ↗
• MalfunctionJun 27, 2023Inaccurate Information; Inaccurate Information

  THE END USER REPORTED THAT THE 0MM ASSEMBLY SCREW WAS TOO SHORT AND COULDN'T BE USE TO ATTACH THE PROXIMAL AND DISTAL BODY OF THE REVIVE HUMERAL PROSTHESIS TO EACH OTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213644 ↗
• MalfunctionJun 27, 2023Inaccurate Information; Inaccurate Information

  THE END USER REPORTED THAT THE 0MM ASSEMBLY SCREW WAS TOO SHORT AND COULDN'T BE USE TO ATTACH THE PROXIMAL AND DISTAL BODY OF THE REVIVE HUMERAL PROSTHESIS TO EACH OTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213495 ↗
• MalfunctionJun 16, 2023Component Missing; Device Markings/Labelling Problem; Inaccurate Information; Component Missing; Device Markings/Labelling Problem; Inaccurate Information

  IT WAS REPORTED THAT THE SCREW WHICH WAS IN THE PACKAGE WAS THE WRONG SIZE. THE SIZE WHICH SHOULD HAVE BEEN IN PLACE WAS A 0MM BUT THIS WAS EVEN SHORTER AND NON-EXSISTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17146593 ↗
• MalfunctionJun 7, 2023Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  IT WAS REPORTED THAT A 0MM SHORT ASSEMBLY SCREW WAS PACKAGED IN A PACKAGE WITH A REFERENCE NUMBER OF A REGULAR LENGTH 0MM ASSEMBLY SCREW. THE WRONG SCREW WAS IN THE CORRECT PACKAGING. IT DID NOT AFFECT THE PATIENT OR PROCEDURE START TIME. THE PHYSICIAN WAS ABLE TO CONSTRUCT A HUMERAL STEM JUST NOT WITH THE COMPONENTS THAT THEY WOULD HAVE PREFERRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083493 ↗
• MalfunctionJun 6, 2023Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  IT WAS REPORTED THAT THE ASSEMBLY SCREW WAS TOO SHORT AND WOULD NOT ENGAGE INTO THE REVIVE STEM WHEN PASSED THROUGH THE REVIVE PROXIMAL BODY. THE SCREW WAS FOUND TO BE MEASURING APPROXIMATELY 30MM INSTEAD OF THE TYPICAL 40MM. AN ALTERNATIVE IMPLANT CONSTRUCT WAS REQUIRED TO BE UTILIZED WHICH WAS NOT IDEAL FOR THE PATIENT AND REQUIRED LONGER IMPLANT CONSTRUCT OF 160MM INSTEAD OF THE REQUIRED 130MM WAS UTILIZED AS A RESULT OF THIS INCIDENT. THIS RESULTED IN ADDITIONAL DISTAL HUMERAL BONE BEING LOST TO FACILITATE THIS.

  Patient problems: Insufficient Information

  MAUDE report 17070343 ↗
• MalfunctionMay 30, 2023Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  DURING SURGERY A SCREW FOR A FLEX REVIVE SIZE ZERO PROCEDURE WAS OPENED. THE SURGICAL TEAM NOTICED THAT THE LENGTH OF THE WAS NOT LONG ENOUGH TO ENGAGE WITH THE FEMORAL COMPONENT OF THE IMPLANT. THE PACKAGING OF THE SCREW STATED THAT THE SCREW WAS A SIZE ZERO. A TOTAL OF 2 SIZE ZERO SCREWS WERE OPENED. BOTH HAD THE SAME SHORTER LENGTH. IMPLANT WAS THEN CHANGED TO A THINNER BUT LONGER FLEX REVIVE SYSTEM IN ORDER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO FURTHER IMPACT TO THE PATIENT HAS BEEN REPORTED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17026942 ↗
• MalfunctionMay 30, 2023Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  DURING SURGERY A SCREW FOR A FLEX REVIVE SIZE ZERO PROCEDURE WAS OPENED. THE SURGICAL TEAM NOTICED THAT THE LENGTH OF THE WAS NOT LONG ENOUGH TO ENGAGE WITH THE FEMORAL COMPONENT OF THE IMPLANT. THE PACKAGING OF THE SCREW STATED THAT THE SCREW WAS A SIZE ZERO. A TOTAL OF 2 SIZE ZERO SCREWS WERE OPENED. BOTH HAD THE SAME SHORTER LENGTH. IMPLANT WAS THEN CHANGED TO A THINNER BUT LONGER FLEX REVIVE SYSTEM IN ORDER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO FURTHER IMPACT TO THE PATIENT HAS BEEN REPORTED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17026941 ↗
• MalfunctionMay 15, 2023Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  IT HAS BEEN REPORTED THAT WHILE TRYING TO ASSEMBLE THE IMPLANT, IT WAS DETECTED THAT THE SCREW WAS OF SUCH A SHORT LENGTH THAT IT DID NOT JOIN OR ASSEMBLE THE TWO PIECES. A SECOND IMPLANT OF THE SAME REFERENCE WAS OPENED THAT CAME WITH THE SAME DEFECT. AND THEN, IT WAS DECIDED TO USE A LONGER STEM, WHOSE ASSEMBLY SCREW WAS CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16934815 ↗
• MalfunctionMay 15, 2023Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  IT HAS BEEN REPORTED THAT WHILE TRYING TO ASSEMBLE THE IMPLANT, IT WAS DETECTED THAT THE SCREW WAS OF SUCH A SHORT LENGTH THAT IT DID NOT JOIN OR ASSEMBLE THE TWO PIECES. A SECOND IMPLANT OF THE SAME REFERENCE WAS OPENED THAT CAME WITH THE SAME DEFECT. AND THEN, IT WAS DECIDED TO USE A LONGER STEM, WHOSE ASSEMBLY SCREW WAS CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16934813 ↗
• MalfunctionApr 21, 2023Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT THERE WAS A REVISION SURGERY WITH THE ORIGINAL INTENT ON PERFORMING A SPHERE/POLY SWAP. UPON INSPECTION, PATIENT HAD A LOOSE REVIVE STEM AND NEEDED A NEW ONE. AFTER PREP, THE DECISION WAS MADE TO GO WITH A 130MM FULLY COATED DISTAL STEM INSTEAD OF THE ORIGINAL PARTIALLY COATED STEM. WHEN PUTTING THE 0MM ASSEMBLY SCREW DOWN THE 11MM PROXIMAL BODY, THE 11MM DISTAL STEM WOULDN'T ENGAGE THE SCREW. AFTER MINUTES OF TRYING TO ASSEMBLE WITH NO SUCCESS, THE SCREW WAS NOTICEABLY SHORTER. A 0S SCREW WAS IN THE REGULAR 0MM SKU. THIS CAUSED A TIME DELAY IN CASE. THE PATIENT WAS TOO SMALL TO GO TO A 150MM LENGTH FOR USE. WITH NO OTHER OPTION AVAILABLE, THE PHYSICIAN USED THE 0MM SCREW THAT WAS IN THE ORIGINAL STEM.

  Patient problems: Insufficient Information

  MAUDE report 16792206 ↗
• MalfunctionApr 21, 2023Migration; Migration

  IT WAS REPORTED THAT THERE WAS A REVISION SURGERY WITH THE ORIGINAL INTENT ON PERFORMING A SPHERE/POLY SWAP. UPON INSPECTION, PATIENT HAD A LOOSE REVIVE STEM AND NEEDED A NEW ONE. AFTER PREP, THE DECISION WAS MADE TO GO WITH A 130MM FULLY COATED DISTAL STEM INSTEAD OF THE ORIGINAL PARTIALLY COATED STEM. WHEN PUTTING THE 0MM ASSEMBLY SCREW DOWN THE 11MM PROXIMAL BODY, THE 11MM DISTAL STEM WOULDN'T ENGAGE THE SCREW. AFTER MINUTES OF TRYING TO ASSEMBLE WITH NO SUCCESS, THE SCREW WAS NOTICEABLY SHORTER. A 0S SCREW WAS IN THE REGULAR 0MM SKU. THIS CAUSED A TIME DELAY IN CASE. THE PATIENT WAS TOO SMALL TO GO TO A 150MM LENGTH FOR USE. WITH NO OTHER OPTION AVAILABLE, THE PHYSICIAN USED THE 0MM SCREW THAT WAS IN THE ORIGINAL STEM.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Insufficient Information

  MAUDE report 16791585 ↗