MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV INSERT 39MM 6TH A 17.5DG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number DWF391A

Device Problem Loss of Osseointegration (2408)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Date 01/23/2024

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device disposition unknown.

Event Description

Bony resorption along the greater tuberosity and an enlarging effusion around the proximal humerus were observed.A revision surgery was conducted, removing components such as the tray, stem, glenosphere, and insert.The relatedness to the study device was definite, while its relation to the surgical procedure was considered possible.

Manufacturer Narrative

The reported event was not 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 for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

Bony resorption along the greater tuberosity and an enlarging effusion around the proximal humerus were observed.A revision surgery was conducted, removing components such as the tray, stem, glenosphere, and insert.The relatedness to the study device was definite, while its relation to the surgical procedure was considered possible.

• Brand Name: TORNIER FLEX SHOULDER SYS REV INSERT 39MM 6TH A 17.5DG
• 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: 18965673
• MDR Text Key: 338434406
• Report Number: 3000931034-2024-00127
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700434020304
• UDI-Public: 03700434020304
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

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 Expiration Date: 10/03/2023
• Device Catalogue Number: DWF391A
• Device Lot Number: 1141AU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/23/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2018
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 61 KG