MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM ANATOMIC AUG SMALL RIGHT KEELED 15 DG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWK503RA15
Medical Device Problem Codes	Off-Label Use (1494); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Discomfort (2330); Inadequate Osseointegration (2646); Muscle/Tendon Damage (4532); Radiolucent Lines (4848)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed since evidence was provided, based on images and reported information.The returned device inspection revealed the following: the identification of the device is confirmed.Bone and soft tissue residues are observed on the device.Surfaces of the device are degraded scratches, pitting marks, deformed material and edges.Since images and information were provided, the opinion of a medical expert was sought and stated as follows both the humeral and glenoid components are well-positioned.This was also mentioned in the notes of the complaint that humeral implants were well fixed.No specific factors, especially no decentering of the humeral component relative to the glenoid.Consequently, no clear radiological signs of rotator cuff dysfunction.There is a radiolucent line around at the glenoid component-bone interface.Radiologically no absolute signs of loosening, no migration, intraoperatively it was mentioned, however.No unintended humeral head-glenoid mismatch on the x-ray.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.According to the humeral head-glenoid combinations recommended in the current tornier perform anatomic augmented glenoid operative technique, the head-glenoid combination in this case is within an unacceptable mismatch range, combination of a 50 into16 size humeral head with a small size glenoid.Based on the investigation, the root cause was attributed to a user related issue.The failure was caused by an off-label use, unacceptable head-glenoid combination.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that, the patient underwent a right primary anatomic shoulder replacement on (b)(6) 2024.Advised by surgeon yesterday that the patient now requires a revision (removal of all implants), and conversion to a reverse shoulder replacement, as the patient's rotator cuff has failed.The surgery was scheduled for (b)(6) 2026.Right primary shoulder arthroplasty on (b)(6) 2024.Patient had been complaining of discomfort in prosthetic right shoulder joint approx 6 months post-op.X-ray at this time showed some evidence of lucency around glenoid component.Ct scan at 12 months post-op showed increasing lucency.He complained of more discomfort.Ct scan late 2025 showed loose glenoid component, revision surgery booked.Simpliciti head removed, simpliciti nucleus was solid, but the revision tools got it out quite clean.Minimal bone loss.Glenoid perform plus poly was very loose, cavity behind it.Component had minimal cement still adhered to it.Multiple tissue samples taken, though surgeon stated that there were no clinical signs of infection.Copious lavage.Shoulder joint reduced, stable through full range of motion.Explanted prosthesis being returned (in a steri-peel pkt) with loan instruments.

• Brand Name: TORNIER PERFORM ANATOMIC AUG SMALL RIGHT KEELED 15 DG
• 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 ; 2018315000
• MDR Report Key: 25152859
• Report Number: 0001649390-2026-00424
• Device Sequence Number: 13449360
• Product Code: KWS
• UDI-Device Identifier: 00846832090587
• UDI-Public: (01)00846832090587(11)230907(17)280907
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: DWK503RA15
• Device Lot Number: BP0822199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• 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: 58 YR
• Patient Sex: Unknown