MAUDE Adverse Event Report: TORNIER S.A.S. AEQREVSD FX/ADAPTER LATRLZD HMRL INSRT DIA36MM LATERALIZ+6MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWD860
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Joint Dislocation (2374)
Date of Event	09/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that, patient's shoulder replacement dislocated after trauma.Original poly was removed and replaced with a thicker and retentive poly.Original poly was 36mm lateralised 6mm.Replaced with 36mm retentive 12mm.
Event or Problem Description
It was reported that, patient's shoulder replacement dislocated after trauma.Original poly was removed and replaced with a thicker and retentive poly.Original poly was 36mm lateralised 6mm.Replaced with 36mm retentive 12mm.
Additional Manufacturer Narrative
The reported dislocation event could not be confirmed, even though pictures of the removed poly were provided.As noted in the reported event, the poly appears to be in good condition overall, showing no apparent signs of defects or damage.However, based solely on these images, it is not possible to confirm the reported dislocation, additional evidence, such as x-rays, would have been required.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.It is likely that the reported fall contributed to the device dislocation.However, without additional medical documentation, it is not possible to definitively determine the root cause of the dislocation or confirm the reported event.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQREVSD FX/ADAPTER LATRLZD HMRL INSRT DIA36MM LATERALIZ+6MM
• 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 S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23390851
• Report Number: 3000931034-2025-00581
• Device Sequence Number: 10038801
• Product Code: KWS
• UDI-Device Identifier: 03700434023176
• UDI-Public: (01)03700434023176(11)250417(17)300417(21)6686BB029
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: DWD860
• Device Lot Number: 6686BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• 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: Female