MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 3/4 36MM DIA +0 45% VE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWS2360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Limb Fracture (4518)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional 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 in a supplemental report.
Event or Problem Description
A revision surgery was planned using the blueprint planning feature.This was a revision surgery with tornier implants, the patient was unstable after the original surgery.The patient is a 76 yo female who suffered a proximal humerus fracture where the surgeon originally treated using our perform fracture stem.On the revision case the surgeon removed the original 36 mm standard glenosphere and 36 3/4 vitamin e 0mm poly liner.He replaced the sphere and poly with a 39 mm standard glenosphere and 39 3/4 0mm ve poly for stability.The surgery was a success and the patient was reduced without any further instability issues due to upsize in the sphere.
Additional Manufacturer Narrative
The reported event could be confirmed.The device was not returned but evidences were provided, based on provided images and reported information, which match the alleged failure.A device inspection was not possible since the affected device was not returned for investigation.Since data and images were provided, the opinion of a medical expert was sought and stated as follows: from the provided information and images, the dislocation is confirmed on ct.I can conclude that the dislocation most likely was caused by a patient related issue due to insufficient soft tissue tension.It was solved by implanting a bigger glenosphere and a conforming new liner (that is compulsory after changing the size of the glenosphere).The implants themselves were intact, well-positioned and well fixated to the bone.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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 any additional information is provided, the investigation will be reassessed.
Event or Problem Description
A revision surgery was planned using the blueprint planning feature.This was a revision surgery with tornier implants, the patient was unstable after the original surgery.The patient is a 76 yo female who suffered a proximal humerus fracture where the surgeon originally treated using our perform fracture stem.On the revision case the surgeon removed the original 36 mm standard glenosphere and 36 3/4 vitamin e 0mm poly liner.He replaced the sphere and poly with a 39 mm standard glenosphere and 39 3/4 0mm ve poly for stability.The surgery was a success and the patient was reduced without any further instability issues due to upsize in the sphere.

• Brand Name: PERFORM REV INSERT SZ 3/4 36MM DIA +0 45% VE
• Common Device Name: 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22074124
• Report Number: 0001649390-2025-00336
• Device Sequence Number: 9301563
• Product Code: PHX
• UDI-Device Identifier: 00846832078059
• UDI-Public: 00846832078059
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: DWS2360
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female