MAUDE Adverse Event Report: TORNIER INC PERFORM COCR HUMERAL HEAD 43X16; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	DWN4316
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/08/2024
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.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "subject: (b)(6) phs study.Early failure of the anatomical prosthesis: the participant experienced an early failure of the anatomical prosthesis.X-rays of the left shoulder (a.P., outlet, axial) from (b)(6) 2024 revealed an increase in anterosuperior escape, especially visible on the axial images, with an acromiohumeral distance (ahd) of approximately 5 mm.The prosthesis remained firmly in place.The surgeon does not yet confirm the relatedness.The plan was to do a conversion to an inverse prothesis with the stem remained.The revision surgery (conversion from anatomic to inverse prothesis) was conducted on (b)(6) 2024.
Event or Problem Description
As reported: "subject: 008-037 phs study early failure of the anatomical prosthesis: the participant experienced an early failure of the anatomical prosthesis.X-rays of the left shoulder (a.P., outlet, axial) from 20.08.2024 revealed an increase in anterosuperior escape, especially visible on the axial images, with an acromiohumeral distance (ahd) of approximately 5 mm.The prosthesis remained firmly in place.The surgeon does not yet confirm the relatedness.The plan was to do a conversion to an inverse prothesis with the stem remained.The revision surgery (conversion from anatomic to inverse prothesis) was conducted on 25 sep 2024.".
Additional Manufacturer Narrative
Please note correction to the following sections following product return: d1 product long description d2a/b product code and common device name d4 catalog #, lot/serial #, and gtin the reported event could be confirmed based on the medical expert opinion and since the product was returned for evaluation and matches the alleged failure mode.A review of the x-rays by the medical expert stated the device was used as intended.The reported issue is confirmed and the x-ray indeed shows superior humeral migration over time which is indicative for progressive rotator cuff failure.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.Based on investigation and formal medical expert opinion the root cause was attributed to patient related issue since the implant was placed correctly and still well-fixated at the time of the ae that led to the revision.If the device is returned or any further information is provided the complaint report will be updated.

• Brand Name: PERFORM COCR HUMERAL HEAD 43X16
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20640358
• Report Number: 0001649390-2024-00634
• Device Sequence Number: 17993152
• Product Code: PAO
• UDI-Device Identifier: 00846832084173
• UDI-Public: 00846832084173
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: DWN4316
• Device Lot Number: 3323AX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2021
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 90 KG