MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED STANDARD GLENOSPHERE DIA 42MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWJ014
Medical Device Problem Codes	Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Inadequate Osseointegration (2646)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the patient underwent a right primary reverse shoulder arthroplasty.At approximately two-year follow-up, the patient presented with shoulder pain and reduced range of motion.The surgeon noted reported non-compliance with postoperative rehabilitation and a history of potential trauma while climbing in and out of a truck.During revision surgery, the glenoid component was found to be loose and dissociated from the glenoid bone and was easily removed.The humeral component remained well fixed and was retained.The polyethylene insert exhibited eccentric wear, and grey synovial tissue was observed and excised.Copious lavage was performed.New glenoid components were implanted with the addition of synthetic bone graft.A new humeral polyethylene insert was placed.The shoulder was reduced and found to be stable through range of motion.
Event or Problem Description
It was reported that the patient underwent a right primary reverse shoulder arthroplasty.At approximately two-year follow-up, the patient presented with shoulder pain and reduced range of motion.The surgeon noted reported non-compliance with postoperative rehabilitation and a history of potential trauma while climbing in and out of a truck.During revision surgery, the glenoid component was found to be loose and dissociated from the glenoid bone and was easily removed.The humeral component remained well fixed and was retained.The polyethylene insert exhibited eccentric wear, and grey synovial tissue was observed and excised.Copious lavage was performed.New glenoid components were implanted with the addition of synthetic bone graft.A new humeral polyethylene insert was placed.The shoulder was reduced and found to be stable through range of motion.
Additional Manufacturer Narrative
This device was concomitant and did not contribute to the reported failure.The complaint is closed without further investigation.If additional information becomes available, the record will be reopened.

• Brand Name: TORNIER PERFORM REVERSED STANDARD GLENOSPHERE DIA 42MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): Tornier Inc; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25331633
• Report Number: 0001649390-2026-00502
• Device Sequence Number: 18549030
• Product Code: KWS
• UDI-Device Identifier: 00846832092109
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWJ014
• Device Lot Number: AK3038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male