MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2 36MM DIA +0 45%; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP1360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Numbness (2415); Implant Pain (4561)
Date of Event	11/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "phs stemless ide: (b)(6).Unexpected pain.Subject's dog pulled surgical arm on a walk causing numbness, limp right arm, and pain.Bruising on front of arm.Numbness and tingling and weakness of arm improved with rest, but reports feeling tightness with movement.Pt referral placed.Has only attended one pt treatment as of report date.Reports ongoing pain and stiffness.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.The device inspection was not possible as the product was not returned for investigation.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.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 any further information is provided the complaint report will be updated.

• Brand Name: PERFORM REV INSERT SZ 1/2 36MM DIA +0 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21456853
• Report Number: 0001649390-2025-00104
• Device Sequence Number: 7591405
• Product Code: PHX
• UDI-Device Identifier: 00846832084395
• UDI-Public: 00846832084395
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2025

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: DWP1360
• Device Lot Number: 9243AX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2022
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 73 KG