MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2 36MM DIA +6 45%; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP1366
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
The reported event could be confirmed based on the hcp evaluation on provided x-ray image.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned and the lot number was not communicated.Indications of material manufacturing or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Based on investigation the root cause was attributed to a patient related issue.As the patient had a displaced proximal humeral fracture where at six months the major tuberosity healed but not completely.Hence the surgeon opted to treat the patient with the implantation of the perform fracture stem in a reverse configuration.This aligns with the character of these displaced fractures where blood supply to bone fragments is easily disrupted during the trauma.If the device is returned or any further information is provided the investigation report will be reassessed.
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: PERFORM REV INSERT SZ 1/2 36MM DIA +6 45%
• 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: 21606333
• Report Number: 0001649390-2025-00157
• Device Sequence Number: 8756929
• Product Code: PHX
• UDI-Device Identifier: 00846832084418
• UDI-Public: 00846832084418
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• 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: DWP1366
• 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