MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2 33MM DIA +6; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWP1336

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  

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 is unknown.

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

The reported event was not confirmed, since the device was not returned for evaluation and no other evidence was 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

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.

• Brand Name: PERFORM REV INSERT SZ 1/2 33MM DIA +6
• 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: 19120823
• MDR Text Key: 340339538
• Report Number: 0001649390-2024-00164
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201315
• 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: 05/30/2024

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: DWP1336
• Device Lot Number: 6885AW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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