MAUDE Adverse Event Report: TORNIER INC PERFORM 45% INSERT SZ1/2 36 MM +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP1360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a competitor's artificial humeral head was implanted, but due to difficulty with elevation, it was replaced with a stryker rsa.During this procedure, to remove the competitor's stem, it was necessary to separate the greater tubercle from the shaft.Subsequently, the greater tubercle gradually fractured or rather, it migrated.It was reported that the patient had a fracture of the greater tubercle around the stem.Debridement was performed on (b)(6).Bone fragments and cement particles were removed.While there were no issues with stability, the procedure concluded by filling the slight gap between the stem and the proximal end with cement.But then dislocation was found, and revision surgery was performed on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned.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.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.If the device is returned or if any additional information is provided the investigation will be reassessed.
Event or Problem Description
It was reported that a competitor's artificial humeral head was implanted, but due to difficulty with elevation, it was replaced with a stryker rsa.During this procedure, to remove the competitor's stem, it was necessary to separate the greater tubercle from the shaft.Subsequently, the greater tubercle gradually fractured or rather, it migrated.It was reported that the patient had a fracture of the greater tubercle around the stem.Debridement was performed on (b)(6).Bone fragments and cement particles were removed.While there were no issues with stability, the procedure concluded by filling the slight gap between the stem and the proximal end with cement.But then dislocation was found, and revision surgery was performed on (b)(6) 2025.

• Brand Name: PERFORM 45% 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): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23550242
• Report Number: 0001649390-2025-00818
• Device Sequence Number: 21275919
• Product Code: PHX
• UDI-Device Identifier: 00846832084395
• UDI-Public: 00846832084395
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: DWP1360
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/13/2026
• 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 Sex: Unknown