MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED STANDARD INSERT 36 MM X 6 MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWB993
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The revision of reversed ii hcp stem was necessary due to instability issues.It was replaced with a cemented stem featuring a constrained insert for enhanced stability.
Event or Problem Description
The revision of reversed ii hcp stem was necessary due to instability issues.It was replaced with a cemented stem featuring a constrained insert for enhanced stability.
Additional Manufacturer Narrative
The reported event was confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received pe liner shows significant signs of long-term implantation, as it is highly worn and deformed.The device history record could not be reviewed because as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.However, on the available x-rays medical opinion was sought from an experienced independent medical expert as below, ¿yes, the image clearly shows a dislocation of the reverse total shoulder arthroplasty, so the event can be confirmed.¿ based on investigation, definitive root cause could not be determined, most likely the possible root cause is a patient related issue.Usually in case of a patient with insufficient soft tissue tension, allows too much ¿joint play¿ which will eventually damage the pe liner to such an extent that containment is diminished, and complete joint dislocation may happen.If any further information is provided, the complaint report will be updated.

• Brand Name: AEQUALIS REVERSED STANDARD INSERT 36 MM X 6 MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18659302
• Report Number: 3000931034-2024-00045
• Device Sequence Number: 20848901
• Product Code: KWS
• UDI-Device Identifier: 03700386916540
• UDI-Public: 03700386916540
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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: DWB993
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 06/12/2024
• 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: 82 YR
• Patient Sex: Female