Tornier Perform® Reversed Glenoid DWJ738Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00846832091270), received between Jul 18, 2022 and Sep 8, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  A revision surgery is to be performed as a result of an alleged infection.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50668287 ↗
• InjuryFeb 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, THE PRIMARY SURGERY WAS CONDUCTED ON (B)(6) 2025. DISLOCATION OF THE GLENOID COMPONENT WAS REPORTED. THE IMPACT ON PAIN AND RANGE OF MOTION WAS UNCLEAR. THE PHYSICIAN COMMENTED THAT THE CAUSE WAS THE PATIENT'S BONE QUALITY ISSUES AND THE INHERENTLY LOW BONE STOCK IN THE GLENOID CAVITY. IMAGES OF X-RAY ARE UNAVAILABLE. THE REVISION SURGERY WAS CONDUCTED ON (B)(6) 2026.

  Patient problems: Subluxation

  MAUDE report 24280104 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6). (B)(4) STUDY. REPLACEMENT OF THE COMPLETE PROSTHESIS DUE TO CHRONIC LOW-GRADE INFECTION. (LEUKOCYTES 8. G/L, CRP 17.7 MG/L, CELL COUNT: 12,300, 98% POLYNUCLEAR: MIBI FROM PUNCTURE: RENEWED DETECTION OF CUTIBACTERIUM ACNES IN THE CULTURE, PENICILLIN-SENSITIVE).

  Patient problems: Unspecified Infection

  MAUDE report 24232090 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT LEFT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2025. PT EXPERIENCED A VERY POSITIVE POST-OP REHAB / RECOVERY, DEMONSTRATING (ACCORDING TO THE SURGEON) A FULL RANGE OF MOTION OF HIS PROSTHETIC SHOULDER JOINT, WITHIN 6 WEEKS POST-OP. LATER, PATIENT WAS RIDING A PUSH BIKE (IN THE EARLY HOURS OF THE MORNING), AND FELL OFF, DISLOCATING HIS LEFT SHOULDER JOINT. UNABLE TO BE CLOSED REDUCED. SURGEON DECIDED ON A MUA, BOOKED FOR ON (B)(6) 2025. JOINT REDUCED, UNDER ANESTHESIA, BUT GROSSLY UNSTABLE. SURGEON DECIDED ON AN OPEN PROCEDURE. TORNIER FLEX REVERSED 0MM TRAY WAS REMOVED, ALONG WITH THE TORNIER REVERSED INSERT 39MM/9MM, AND A THICKER TRAY (6MM) AND (SAME SIZE) NEW INSERT WERE IMPLANTED. ON REDUCTION, THE JOINT WAS STILL UNSTABLE. SURGEON DISLOCATED THE JOINT, REMOVED THE NEW REVERSE TRAY / POLY INSERT, AND PROCEEDED TO EXPLORE FOR FURTHER CAUSES OF THE IMPINGEMENT / INSTABILITY. MORE POSTERO-INFERIOR GLENOID BONE WAS REMOVED. THE (PRIMARY) IMPLANTED 39MM STANDARD GLENOSPHERE WAS THEN REMOVED, REPLACED BY A 42MM STANDARD GLENOSPHERE. THE SUPERIOR GLENOID 30MM SCREW WAS FOUND TO BE LOOSE AND REPLACED WITH A 34MM SCREW. A NEW 12MM FLEX REVERSE TR

  Patient problems: Fall; Subluxation

  MAUDE report 24066670 ↗
• MalfunctionDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A REVERSE SHOULDER REPLACEMENT AT THE THE STAGE OF IMPLANTING THE PERIPHERAL SCREWS, THE CONSULTANT ATTEMPTED TO REMOVE THE 38MM DWJ738 SCREW IN ORDER TO REPLACE IT WITH A SMALLER SIZE. WHILE THE SCREW WAS BEING REMOVED FROM THE BASEPLATE, THE SCREW SNAPPED. THE BREAK OCCURRED WITH PART OF THE SCREW REMAINING EMBEDDED INSIDE THE BASEPLATE, POSITIONED WITHIN THE PATIENT¿S GLENOID. DUE TO THE NATURE OF THE BREAKAGE, IT WAS NOT POSSIBLE TO EXTRACT THE REMAINING PORTION OF THE SCREW FROM EITHER THE BASEPLATE OR THE PATIENT¿S GLENOID. AS A RESULT, THE RETAINED FRAGMENT HAD TO BE LEFT IN SITU.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817124 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PHS STUDY SUBJECT: (B)(6). DEEP INFECTION REQUIRING A MEDICAL INTERVENTION (OPENED DEBRIDEMENT AND IRRIGATION). INFECTION C. ACNES. RE-OPERATION WITHOUT IMPLANT EXTRACTION. DATE OF REOPERATION: (B)(6)2025".

  Patient problems: Unspecified Infection

  MAUDE report 21948049 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INFECTION WAS FOUND IN THE KNEE AND SPINE IMPLANT, AND THE SHOULDER WAS ALSO SUSPECTED OF BEING INFECTED. THE REVISION SURGERY FOR REMOVING IMPLANTS WAS SCHEDULED ON (B)(6) 2025.

  Patient problems: Medical device site infection

  MAUDE report 21699143 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION/ REMOVAL OF REVERSE II HUMERAL/ PERFORM REVERSE GLENOID IMPLANTS AND IMPLANTATION OF CEMENT SPACER DUE TO INFECTION. SURGEON BECAME AWARE 4 WEEKS PRIOR OF INFECTION, DID WASHOUT UNSUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19134709 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION/ REMOVAL OF REVERSE II HUMERAL/ PERFORM REVERSE GLENOID IMPLANTS AND IMPLANTATION OF CEMENT SPACER DUE TO INFECTION. SURGEON BECAME AWARE 4 WEEKS PRIOR OF INFECTION, DID WASHOUT UNSUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19134703 ↗
• InjuryFeb 12, 2024Break; Fracture; Break; Fracture

  THE SALES REP REPORTED, "FOLLOWING A PROBLEM WITH THE DMI SHOULDER PROSTHESIS AT THE HOSPITAL, THE BROKEN SCREW AND THE GLENOSPHERE SCREW WERE NOTED INTRAOPERATIVELY." IN ADDITION, THE CUSTOMER REPORTED, "MOBILIZATION OF GLENOSPHERE PLATE + FUNCTIONAL DEGRADATION FOLLOWING A FALL IN (B)(6) 2022- 1 BROKEN SCREW GLENOSPHERE SCREW BROKEN IN CENTRAL SCREW DIFFICULTY IN EXTRACTING BROKEN SCREW FRAGMENT, PREVENTING EXTRACTION OF PLATE FRAGMENT EXTRACTED USING MICROSURGICAL FORCEPS". PATIENT ALSO REQUIRED ANTIBIO-THERAPY DUE TO THE REVISION SURGERY.

  Patient problems: Failure of Implant; Fall; Unspecified Infection

  MAUDE report 18691904 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS A REVISION SURGERY CAUSED BY AN INFECTION. ADDITIONALLY, ALL TEN IMPLANTS WERE REMOVED. THE NURSE STILL HAD THE CENTRAL SCREW WITHIN THE BASEPLATE AND THE REVERSED INSERT WAS UNATTACHED FROM THE REVERSED TRAY.

  Patient problems: Unspecified Infection

  MAUDE report 16996589 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTION WAS FOUND IN A PATIENT AFTER ARTIFICIAL SHOULDER JOINT SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 16203350 ↗
• InjuryJul 18, 2022Adverse 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 AN INFECTION 12 MONTHS POST-OP. THE METAL DEVICES WERE REMOVED AND A COMPETITOR'S CEMENT SPACER WAS INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 15043899 ↗