MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS MONOBLOC HUMERAL STEM D. 9MM 125 DG COCR L. 115MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWB091
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Subluxation (4525); Joint Laxity (4526)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes with the tornier shoulder system.The report details analysis provided for procedures performed between april 2012 ¿ may 2022.During the review of the report, it was identified that on (b)(6) 2021 a patient required revision surgery due to instability, which was not previously reported to the manufacturer.
Additional Manufacturer Narrative
Correction: h6 clinical code.The reported event could not be 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 was not necessary because the implant affected by this complaint has been manufactured prior to 2018.As a result, this implant is expired and can no longer be put on the market or implanted.The complaint history review found no other complaint recorded for this lot number.Moreover, the post market surveillance reviews have not identified any signals for similar issues that would have challenged the efficacy and safety of this product.A review of the labeling did not indicate any abnormalities.The nature of the complaint doesn¿t necessitate a drawing review.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
The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes with the tornier shoulder system.The report details analysis provided for procedures performed between april 2012 ¿ may 2022.During the review of the report, it was identified that on (b)(6) 2021 a patient required revision surgery due to instability, which was not previously reported to the manufacturer.

• Brand Name: AEQUALIS MONOBLOC HUMERAL STEM D. 9MM 125 DG COCR L. 115MM
• 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: 18592049
• Report Number: 3000931034-2024-00028
• Device Sequence Number: 8183086
• Product Code: KWS
• UDI-Device Identifier: 03700386915185
• UDI-Public: 03700386915185
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K952928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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: DWB091
• Device Lot Number: 7161AN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 74 YR
• Patient Sex: Female