MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED LATERALIZED BASEPLATE 3MM DIA 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWJ502

Device Problem Biocompatibility (2886)

Patient Problems Ossification (1428); Loss of Range of Motion (2032); Metal Related Pathology (4530); Implant Pain (4561)

Event Date 07/17/2023

Event Type  Injury  

Event Description

The patient reported pain and decreased function, leading to a revision surgery.The reason for the revision surgery was listed as heterotopic ossification, severe stiffness, and nickel metal allergy.Components including the tray, insert, and glenosphere were explanted, while the stem, baseplate, and central screw were retained.The relatedness to the study device and the surgical procedure was assessed as 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.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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.H3 other text: device disposition unknown.

• Brand Name: TORNIER PERFORM REVERSED LATERALIZED BASEPLATE 3MM DIA 25MM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18965675
• MDR Text Key: 338434858
• Report Number: 0001649390-2024-00124
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832092123
• UDI-Public: 00846832092123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWJ502
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2024
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 77 KG