MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED STANDARD GLENOSPHERE DIA 42MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ014
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to patient's shoulder being unstable for approximately two months.Tissue cultures and a frozen specimen were collected and showed no bacterial growth.The instability and frequent dislocations had resulted in wear of the +0 thickness poly.Postoperatively, the shoulder was reduced and stable.
Additional Manufacturer Narrative
Correction, d9.The reported event could be confirmed, based on the medical expert opinion provided for the imaging.The device inspection was not possible as the product was not returned for investigation.However, based on images provided medical expert opinion stated below: "based on the provided images, the fixation appears successful, with the implanted components well-positioned.Routine tissue cultures and frozen specimens ruled out infection, indicating no impact on the polyethylene (pe) component.However, imaging reveals polyethylene damage due to instability and repeated subluxation, likely caused by edge-loading.While insufficient soft tissue tension is a common contributor to instability.The exact root cause remains undetermined due to limited data".A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to patient's shoulder being unstable for approximately two months.Tissue cultures and a frozen specimen were collected and showed no bacterial growth.The instability and frequent dislocations had resulted in wear of the +0 thickness poly.Postoperatively, the shoulder was reduced and stable.

• Brand Name: TORNIER PERFORM REVERSED STANDARD GLENOSPHERE DIA 42MM
• 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 NA ; EI NA
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23213594
• Report Number: 0001649390-2025-00684
• Device Sequence Number: 9075725
• Product Code: PHX
• UDI-Device Identifier: 00846832090358
• UDI-Public: (01)00846832090358(11)220727(17)270727(10)CZ5322195029
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: DWJ014
• Device Lot Number: CZ5322195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2022
• 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: 77 YR
• Patient Sex: Male