Tornier HRS ARS655200Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00846832093007), received between Apr 21, 2023 and Aug 17, 2026 — classified as 22 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that the patient underwent implantation of a Revive device. Follow-up X-ray demonstrated that the set screw and locking cap had backed out, resulting in separation of the proximal body from the distal stem. The patient was subsequently scheduled for revision shoulder surgery.During the revision procedure, severe metallosis was observed. The proximal body was reported to have rotated around the central screw and distal stem, resulting in significant wear of the mating teeth on both the proximal body and stem. Metallosis was also noted beneath the glenosphere and baseplate. The baseplate was found to be grossly loose and was easily explanted during the procedure.

  Patient problems: Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 50285844 ↗
• InjuryAug 4, 2026Device Dislodged or Dislocated

  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 50131508 ↗
• 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 23301375 ↗
• 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 AN 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 23301186 ↗
• InjuryAug 1, 2025Device Dislodged or Dislocated; Osseointegration Problem; Migration; Device Dislodged or Dislocated; Osseointegration Problem; Migration

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A DISSOCIATED REVIVE STEM. THE LOCKING CAP AND SCREW WERE CORRECTLY ASSEMBLED BUT BECAME LOOSE POSTOPERATIVELY, REQUIRING SURGICAL INTERVENTION.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 22687098 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6) REVIVE HRS STUDY. PATIENT SEEN FOR SWELLING AND PAIN OF RIGHT SHOULDER (OPERATED SHOULDER) ACCORDING TO THE SURGEON, THIS EVENT IS NOT RELATED TO THE DEVICE OR THE SURGERY.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 22663552 ↗
• MalfunctionJul 21, 2025Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  THE LOCKING CAP WOULDN'T ENGAGE IN THE PROXIMAL BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559725 ↗
• InjuryJul 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Insufficient Information

  MAUDE report 22556100 ↗
• 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 22154000 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2013 ¿ (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 21919093 ↗
• InjuryApr 22, 2025Biocompatibility; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Biocompatibility; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  ORIGINAL PROCEDURE TOOK PLACE IN 2024. PROCEDURE WAS A REVISION OF ANOTHER COMPANIES ANATOMIC SHOULDER REPLACEMENT. REVISION ON A POLY SWAP AND GLENOSPHERE EXCHANGE. X-RAYS IN THEATRE SHOW FLEX REVIVE SCREW AND CAP HAVE BACKED OUT OF PROSTHESIS MAKING THE CONSTRUCT LOOSE. PATIENT SHOWED CLEAR SIGNS OF METALLOSIS AND QUERY INFECTION. ALL IMPLANTS EXTRACTED AND CEMENT SPACER IMPLANTED.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 21880945 ↗
• InjuryFeb 4, 2025Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "REVIVE HUMERAL STEM APPEARS TO BE SEPARATING. THE LOCKING CAP AND THE ASSEMBLY SCREWS SEEM TO BE BACKING OUT CAUSING THE PROXIMAL BODY, THE SPACER AND THE DISTAL STEM TO BE MIGRATING AWAY FROM EACH OTHER."

  Patient problems: Inadequate Osseointegration

  MAUDE report 21307318 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 20508134 ↗
• InjuryJun 25, 2024Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "IT WAS REPORTED THAT A LOOSENING OF THE COMPONENTS WAS DETECTED, AND IT WAS WEARING A LOCKING CAP THAT IS SUPPOSED TO LOCK THE COMPONENTS. AFTER APPROXIMATELY 8 MONTHS OF INITIAL SURGERY, THE PATIENT NOTICED A ¿CLICK¿ AND THEY WENT TO THE EMERGENCY ROOM, WHERE THEY UNDERWENT AN X-RAY SHOWING THE DISASSEMBLY OF THE IMPLANT. HOWEVER, IT WAS NOT UNTIL (B)(6) 2024 THAT THEY WERE SEEN BY A TRAUMATOLOGIST WHO KNEW ABOUT THE IMPLANT AND WAS THE ONE WHO DETECTED THAT THE CONDITION OF THE STEM WAS NOT WHERE IT SHOULD BE. THE INITIAL SURGERY WAS ON (B)(6) 2023 AND A TORQUE SCREWDRIVER WAS USED TO ENSURE THAT THE TIGHTENING TORQUE WAS DONE WITH THE NECESSARY FORCE. THE INITIAL SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANYTHING TO REPORT."

  Patient problems: Inadequate Osseointegration; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19608211 ↗
• InjuryJun 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PATIENT EXPERIENCED A DISLOCATION DUE TO A LOOSE PROXIMAL BODY OF THE REVIVE STEM, POTENTIALLY CAUSED BY A BACKED-OUT ASSEMBLY SCREW AND LOCKING CAP. REVISION SURGERY WAS PERFORMED, REPLACING ALL COMPONENTS EXCEPT FOR THE DISTAL STEM. ADDITIONAL IMPLANTS USED INCLUDED TWO SPACERS, A LOW OFFSET HUMERAL TRAY, AND A POLY INSERT.

  Patient problems: Failure of Implant

  MAUDE report 19466028 ↗
• 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 19464072 ↗
• InjuryApr 22, 2024Osseointegration Problem; Osseointegration Problem

  REMOVAL OF FLEX REVIVE STEM AND WIRES AND REPLACEMENT WITH CEMENT SPACER DUE TO DISTAL HUMERAL (LIKELY) INFECTION AND PROSTHETIC LOOSENING. THE PATIENT HAS RA AND A BONE DENSITY DEFICIENCY. THE REVIVE STEM WAS USED TO STABILIZE THE DISPLACED DISTAL HUMERUS AND CABLES USED TO SECURE THE BONE. THERE WAS EVIDENCE OF LOOSENING OF THE THE DISTAL HUMERUS ONLY AND NO EVIDENCE ON XR OF ANY SHOULDER JOINT ISSUE.

  Patient problems: Inadequate Osseointegration; Rheumatoid Arthritis; Unspecified Infection

  MAUDE report 19159606 ↗
• InjuryMar 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT EXPERIENCED ANOTHER SHOULDER DISLOCATION. X-RAYS SHOWED NO SIGNIFICANT ISSUES, AND THE SURGEON APPROVED THE PATIENT FOR PHYSICAL THERAPY. THE PATIENT BEGAN PHYSICAL THERAPY, WEARING A SLING IN CROWDED AREAS BUT OTHERWISE USING THE ARM AS DIRECTED BY THE PHYSICIAN. THE SURGEON INSERTED A LARGER ROUND PIECE, A STEM, AND A PLASTIC DISC TO FILL THE GAP IN THE SHOULDER. THE SURGEON DISCUSSED THE POSSIBILITY OF TRANSITIONING FROM A REVERSE SHOULDER ARTHROPLASTY (RSA) TO A REGULAR SHOULDER, OR ALTERNATIVELY, FOR THE PATIENT TO CONSIDER LIVING WITH LIMITED SHOULDER FUNCTION, AS FULL USE MAY NOT BE ACHIEVABLE.

  Patient problems: Joint Dislocation

  MAUDE report 19005375 ↗
• 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 18972551 ↗
• 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 18778331 ↗
• InjuryDec 18, 2023Loss of Osseointegration; Noise, Audible; Loss of Osseointegration; Noise, Audible

  AS REPORTED: "PATIENT HAD A REVIVE (IMPLANT) PUT IN ON (B)(6) 2023. PATIENT CAME BACK COMPLAINING OF PAIN AND A CLICKING. DR. SCHEDULED FOR A REVISION ON (B)(6) 2023 AND IT WAS DISCOVERED THAT THE ASSEMBLY SCREW HAD COME LOOSE AND THE PROXIMAL BODY WAS ROTATING".

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 18352809 ↗
• InjuryNov 14, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT A PATIENT HAD INCREASED PAIN DUE TO JUNCTIONAL FAILURE AND LOOSENING. ADDITIONALLY, IT WAS REPORTED: "IF THE ASSEMBLY SCREWS AND LOCKING CAP WERE NOT PROPERLY TORQUED, THE LOCKING CAP LOOSENS AND COMES OUT OF IT¿S SPOT WHEN THE ASSEMBLY SCREWS STARTS BACKING OUT. THE ASSEMBLY SCREW IS CRITICAL FOR ALL THE COMPONENTS (IN THIS CASE THE PROXIMAL BODY AND THE DISTAL STEM) TO STAY ASSEMBLED. SO IN REALITY, THE DISTAL STEM IS NOT THE COMPONENT THAT DISASSEMBLED, THE ENTIRE CONSTRUCT DISASSEMBLED DUE TO THE FAILURE OF THE ASSEMBLY SCREW AND LOCKING CAP."

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 18134079 ↗
• InjuryOct 10, 2023Osseointegration Problem; Osseointegration 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; Inadequate Osseointegration

  MAUDE report 17906722 ↗
• 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 16791943 ↗