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

Catalog Number UNK_WTM

Device Problem Naturally Worn (2988)

Patient Problem Loss of Range of Motion (2032)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

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 possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as neither the lot number nor the catalog number was communicated.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.The event description describes that ¿patient required revision surgery due stiffness and glenoid implant wear¿.It is possible these issues were the result of scapular notching which refers to the erosion of the bone inferior along the lateral scapular neck just medial to the glenoid baseplate.Many reports have detailed a high incidence of notching at medium-to-long term follow-up based on radiographs without much initial clinical consequence.However, severe notching can erode the glenoid bone resulting in a loosened glenoid component or glenoid sphere wear (due to the friction with the humeral component) requiring revision.Notching depends on certain prosthetic designs, anatomic and surgical factors.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event 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The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes with the tornier shoulder system.The report details analysis provided for procedures performed between (b)(6) 2012 ¿ (b)(6) 2022.During the review of the report, it was identified that on (b)(6) 2019 a patient required revision surgery due stiffness and glenoid implant wear, which was not previously reported to the manufacturer.

• Brand Name: UNKNOWN - COMPRESSION 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: 17982318
• MDR Text Key: 326237393
• Report Number: 3000931034-2023-00362
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2023
• 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: 09/27/2023
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 74 KG