MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC TORNIER PERFORM REVERSED STANDARD GLENOSPHERE DIA 39MM; shoulder prosthesis, reverse configuration

Catalog Number	DWJ013
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2026
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
The procedure took place due to chronic dislocation.Once the surgeon got exposure, the tray and poly were removed and the poly had medial wear.
Event or Problem Description
The procedure took place due to chronic dislocation.Once the surgeon got exposure, the tray and poly were removed and the poly had medial wear.
Additional Manufacturer Narrative
Correction: d4 lot number.The reported event was not confirmed, since no medical imaging of the alleged dislocation was provided.The device inspection revealed the following: a visual inspection of the returned device shows evidence of normal wear consistent with use.Light surface scratches are present on the curved articulating surface of the glen sphere.The opposite side of the device also exhibits signs of normal wear, with no significant damage or abnormalities observed.Based on the investigation, the root cause could not be determined.The returned device exhibits signs of normal wear.Without medical imagining it cannot be determined if the device attributed to the reported dislocation.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.If more information is provided, the case will be reassessed.

• Brand Name: TORNIER PERFORM REVERSED STANDARD GLENOSPHERE DIA 39MM
• Common Device Name: shoulder prosthesis, reverse configuration
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• 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 ; +1(201)831-5000
• MDR Report Key: 25217219
• Report Number: 0001649390-2026-00449
• Device Sequence Number: 18594506
• Product Code: PHX
• UDI-Device Identifier: 00846832061907
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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 Expiration Date: 09/12/2025
• Device Catalogue Number: DWJ013
• Device Lot Number: CZ2520212
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2020
• 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