MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX38MM STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ738
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/10/2025
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.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "phs study subject: (b)(6).Deep infection requiring a medical intervention (opened debridement and irrigation).Infection c.Acnes.Re-operation without implant extraction.Date of reoperation: on (b)(6) 2025.".
Additional Manufacturer Narrative
Please note correction to d4 (catalog #).The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided to confirm the alleged issue.A device inspection was not possible since the affected device was not returned for investigation.A review of the pre and post-op x-rays with a formal medical expert opinion stated: ¿the device was appropriately used for the intended clinical indication and was positioned correctly.Cutibacterium acnes a skin bacterium commonly found in the shoulder region, is frequently associated with periprosthetic joint infections in shoulder arthroplasty.¿ a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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 investigation, the root cause was attributed to a patient related factor.If any further information is provided the complaint report will be updated.
Event or Problem Description
As reported: "phs study subject: (b)(6).Deep infection requiring a medical intervention (opened debridement and irrigation).Infection c.Acnes.Re-operation without implant extraction.Date of reoperation: (b)(6)2025".

• Brand Name: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX38MM STERILE
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21948049
• Report Number: 0001649390-2025-00298
• Device Sequence Number: 21041879
• Product Code: PHX
• UDI-Device Identifier: 00846832091270
• UDI-Public: (01)00846832091270(11)230110(17)280110
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 08/04/2025

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: DWJ738
• Device Lot Number: AE8425
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2023
• 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 Age: 80 YR
• Patient Sex: Male
• Patient Weight: 77 KG