MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN_WRIGHT TORNIER-MONTBONNOT_PRODUCT; SHOULDER JOINT METAL PROSTHESIS

Catalog Number UNK_WTM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Pain (1994)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device not accessible for testing.

Event Description

It was reported that a patient underwent a revision surgery due to arthritic progression in left shoulder, with pain, 4 years after primary surgery (hsa - hemi shoulder arthroplasty in 2017).Patient id: (b)(6).Current study shoulder: left - primary diagnosis: painful hsa with arthritic progression.Hsa in 2017.The revision was reported on a primary study surgery form, so an ae would not need to be reported through shout as this patient wasn¿t in the study yet.

• Brand Name: UNKNOWN_WRIGHT TORNIER-MONTBONNOT_PRODUCT
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• 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: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 11884504
• MDR Text Key: 252693743
• Report Number: 3000931034-2021-00258
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/26/2021

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/26/2021
• 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: 56 YR
• Patient Weight: 100