MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS LNG HUM PTC STEM 3B 132.5DG 98MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number DWF613B

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

Patient Problems Bacterial Infection (1735); Loss of Range of Motion (2032); Implant Pain (4561)

Event Date 03/19/2024

Event Type  Injury  

Event Description

As reported: "patient underwent shoulder hemi-arthroplasty on (b)(6) 2023, for fracture proximal right humerus.Patient has experienced pain and reduced range of motion over recent months.Surgeon suspects joint is infected, due to 1 x swab returning positive for bacteria c.Acnes.Surgeon has decided on a 2-stage revision arthroplasty.Humeral prosthesis removed, with significant difficulty (humeral stem well fixed).Multiple tissue specimens taken.Explanted prosthesis discarded.Cement antibiotic spacer implanted.".

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 in a supplemental report.H3 other text : device was discarded.

• Brand Name: TORNIER FLEX SHOULDER SYS LNG HUM PTC STEM 3B 132.5DG 98MM
• 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: 19105749
• MDR Text Key: 340158227
• Report Number: 3000931034-2024-00207
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700434021660
• UDI-Public: 03700434021660
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K190521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWF613B
• Device Lot Number: CZ1321274
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/15/2024
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 105 KG