MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED FRACTURE CONSTRAINED INSERT 42X12MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWD978
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Subluxation (4525); Insufficient Information (4580)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the second revision surgery that occurred on (b)(6) 2023 from retentive +12 (dwd978) & lateralised 29x42mm (dwd194) glenosphere then to a spacer (dwd920) and +6mm insert (dwd976) and eccentric glenosphere (dwd195).No further information was provided.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.The other linked report numbers will be provided with the supplemental report once we will have the numbers for them.
Event or Problem Description
It was reported that, the second revision surgery that occurred on (b)(6) 2023 from retentive +12 (dwd978) & lateralised 29x42mm (dwd194) glenosphere then to a spacer (dwd920) and +6mm insert (dwd976) and eccentric glenosphere (dwd195).No further information was provided.Later, it was reported during third revision that, background on the patient is that he sadly has an alcohol problem hence the many falls leading to dislocations, not compliant with rehab.,with an increased risk of infection.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labelling did not indicate any abnormalities.It is specified in the ifu as follows: the following situations threaten the success of the shoulder replacement implant, people likely to fall, alcoholism or drug abuse, inability of the patient to follow the surgeon's recommendations and the physical therapy program.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.Based on the investigation, the root cause was attributed to a patient related issue.The event was most likely caused by a patient's failure to follow instructions (alcohol problem resulting in numerous falls, dislocations and revisions, with an increased risk of infection).If any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQUALIS REVERSED FRACTURE CONSTRAINED INSERT 42X12MM
• 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: 24322771
• Report Number: 3000931034-2026-00130
• Device Sequence Number: 10049753
• Product Code: KWS
• UDI-Device Identifier: 03700386936401
• UDI-Public: 03700386936401
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: DWD978
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 60 YR
• Patient Sex: Male