MAUDE Adverse Event Report: TORNIER INC PERFORM 10 DEG 55% INSERT SZ1/2 36 MM +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWR3360
Medical Device Problem Codes	Loss of Osseointegration (2408); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, the insert came off.No further information was provided.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Correction in lot number and serial number (section d4), correction in manufacturing site for devices (section g1).The reported event could not be confirmed since the device was returned for evaluation does not match the alleged failure.A device inspection revealed the following a visual inspection revealed the returned poly insert revealed significant damage to the poly insert.The articulating surface has multiple scratches and gouges throughout.Along the outer circumference of the device there is minimal gouging.Most of the surface area is smooth and in good condition.The underside of the implant is in extremely poor condition.The poly is very damaged with numerous scratches, gouges and overall rough appearance to the edge of the underside area.No damage or defect was noted with the metal lock ring that circumvents the underside of the device.It is positioned correctly as per specifications.A function inspection of the returned poly insert revealed the insert can be seated in our split test fixture as intended despite the significant damage noted in the returned part.When performing the functional test, the device was lined up with the fixture, hand pressure was applied and then three impactions were performed using the appropriate impactor instruments per the surgical technique.After the device was impacted, an attempt was made to pull the device off the fixture and it was found to be adequately seated and could not be pulled away from the fixture.A review of the device history for the reported lot did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation and provided information, the root cause was attributed to user related issue.It appears the instructions in the surgical technique may not have been properly followed.The user is instructed to- apply hand pressure to begin to engage the locking mechanism and then impact the poly three times.Failure to following the technique can result in the insert and stem construct to be unstable and cause the insert to come off the stem as noted in this complaint.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that; the insert came off.No further information was provided.

• Brand Name: PERFORM 10 DEG 55% INSERT SZ1/2 36 MM +0
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork 38330 ; EI 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22850067
• Report Number: 0001649390-2025-00578
• Device Sequence Number: 4488484
• Product Code: PHX
• UDI-Device Identifier: 00846832084937
• UDI-Public: (01)00846832084937(11)230614(17)280614(21)AF8433000
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/11/2025

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: Lay User/Patient
• Device Catalogue Number: DWR3360
• Device Lot Number: AF8433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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 Sex: Female