MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED LATERALIZED GLENOSPHERE +3 DIA 36MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Malunion of Bone (4529)
Date of Event	02/19/2024
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
As reported: subject: (b)(6) perform fracture study.Post-operative complication: malunion/nonunion.At 6m imaging appointment the images show no bone consolidation.
Additional Manufacturer Narrative
It has been determined that this device is concomitant and did not contribute to the reported failure.Therefore, mfr report # 0001649390-2025-00158 is no longer valid or applicable and this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
As reported: "subject: (b)(6) perform fracture study.Post-operative complication: malunion/nonunion at 6m imaging appointment the images show no bone consolidation.".

• Brand Name: TORNIER PERFORM REVERSED LATERALIZED GLENOSPHERE +3 DIA 36MM
• 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: 21606334
• Report Number: 0001649390-2025-00158
• Device Sequence Number: 18332089
• Product Code: PHX
• UDI-Device Identifier: 00846832090372
• UDI-Public: 00846832090372
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2025

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: DWJ022
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/26/2025
• 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: Other
• Patient Age: 58 YR
• Patient Sex: Unknown
• Patient Weight: 108 KG