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

Catalog Number UNK_WTB

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

Patient Problem Arthritis (1723)

Event Date 08/15/2023

Event Type  Injury  

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.H3 other text : device disposition is unknown.

Event Description

During a revision surgery for a plated olecranon fracture and radial head replacement, the patient received a total elbow due to arthritic changes resulting from a previous fracture.A phone call with a representative confirmed that the radial head and stem used were tornier components, while the plates and screws in the patient were synthese.

Event Description

During a revision surgery for a plated olecranon fracture and radial head replacement, the patient received a total elbow due to arthritic changes resulting from a previous fracture.A phone call with a representative confirmed that the radial head and stem used were tornier components, while the plates and screws in the patient were synthese.

Manufacturer Narrative

Please note the corrections made to the: fda registration number 1649390, d3: manufacturer entity, and g1: manufacturing site: 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.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.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.

• Brand Name: UNKNOWN PRESS FIT RADIAL HEAD
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin MN 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17712758
• MDR Text Key: 322987516
• Report Number: 0001649390-2023-00221
• 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,Followup
• Report Date: 11/06/2023

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_WTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 11/06/2023
• 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 Sex: Female