MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN SCREW; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_WTM

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2024

Event Type  malfunction  

Event Description

The patient required a revision surgery due to the disassociation of the sphere from the baseplate.Original implant details and implantation timing were unavailable as they were done by a different surgeon at a different facility.The sphere's movement caused extensive wear on the poly and metal components, as well as the baseplate.Despite planning to remove the baseplate, it was impossible due to cold welding of screws.Instead, they reattached the sphere.The original implants included a flex stem with a reverse ii baseplate/sphere.In the update, a tray, poly, and the sphere were removed and reinserted.Only dwf362b and dwf502 implants were used.Post-op x-rays were sent previously, and additional ones will be provided.While attempting to remove all glenoid components, only one screw was removed, and the other three remained due to their immovability.The original sphere was removed and reimplanted.

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 on a supplemental report.

• Brand Name: UNKNOWN SCREW
• Type of Device: 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: 18914076
• MDR Text Key: 337782870
• Report Number: 3000931034-2024-00115
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male