MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED LATERALIZED GLENOSPHERE +3 DIA 33MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWJ021

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

Patient Problems Loss of Range of Motion (2032); Hyperextension (4523); Muscle/Tendon Damage (4532)

Event Date 03/13/2024

Event Type  Injury  

Event Description

A phs stemless ide subject showed mild anterior impingement along the conjoin tendon, exacerbated by hyperextension and maximal forward flexion.Treatment involved a corticosteroid injection into the conjoin tendon.The issue's relatedness to the device was deemed possible, but it was considered unrelated to the surgery.

Manufacturer Narrative

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

• Brand Name: TORNIER PERFORM REVERSED LATERALIZED GLENOSPHERE +3 DIA 33MM
• 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: 19120877
• MDR Text Key: 340340187
• Report Number: 0001649390-2024-00166
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832090365
• UDI-Public: 00846832090365
• 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: 04/16/2024

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: DWJ021
• Device Lot Number: AE9416
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/16/2024
• 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): Other
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 60 KG