MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 25MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWJ505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision shoulder arthroplasty was performed to convert an antibiotic spacer to a reverse shoulder construct.The patient previously underwent a primary procedure with tornier/stryker implants, which were later explanted due to infection.An antibiotic spacer was placed at that time.During the most recent procedure, the spacer was removed and replaced with a reverse shoulder prosthesis.
Additional Manufacturer Narrative
A supplemental report will be submitted if additional information becomes available.
Additional Manufacturer Narrative
Correction: fda registration number 0001649390 - te (blooming).The reported event was not confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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.Microbiologist reviewed the sterilization procedures, environmental monitoring, bioburden data and the dhr and noted: the subject device was packaged according to established design and process specifications, and was sterilized according to procedure.No deviation for a non-conformance could be found.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that a revision shoulder arthroplasty was performed to convert an antibiotic spacer to a reverse shoulder construct.The patient previously underwent a primary procedure with tornier/stryker implants, which were later explanted due to infection.An antibiotic spacer was placed at that time.During the most recent procedure, the spacer was removed and replaced with a reverse shoulder prosthesis.

• Brand Name: TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 25MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• 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: 23125593
• Report Number: 3000931034-2025-00509
• Device Sequence Number: 9416650
• Product Code: PHX
• UDI-Device Identifier: 00846832092109
• UDI-Public: (01)00846832092109(11)240620(17)290620(10)9194BA043
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: DWJ505
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2024
• 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: 66 YR
• Patient Sex: Male