MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2 36MM DIA +3 10 DG; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWR1363
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Malunion of Bone (4529); Implant Pain (4561)
Date of Event	03/22/2024
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.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "phs study subject: (b)(6).Patient presented with severe pain in left shoulder on (b)(6) 2024.Admitted seen by orthopaedic surgeon x-ray on (b)(6) 2024 showed mildly displaced extra articular transverse fracture left acromion.Ct scan (b)(6) 2024.Repeat x-rays on (b)(6) 2024 and (b)(6) 2024.Repeat ct on (b)(6) 2024.Patient had sling removed 3 weeks ago, continuing with physio.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and provided xray images are insufficient for the hcp evaluation.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.However on the available xrays medical opinion was sought from an experienced independent medical expert as below the event cannot be confirmed on the early postoperative xrays.The implant is well positioned and well fixed.More detailed information or clinical 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 device is returned or any further information is provided the investigation report will be reassessed.
Event or Problem Description
As reported: "phs study subject: (b)(6).Patient presented with severe pain in left shoulder on (b)(6) 2024.Admitted seen by orthopaedic surgeon x-ray on (b)(6) 2024 showed mildly displaced extra articular transverse fracture left acromion.Ct scan (b)(6) 2024.Repeat x-rays on (b)(6) 2024 and (b)(6) 2024.Repeat ct on (b)(6) 2024.Patient had sling removed 3 weeks ago, continuing with physio.".

• Brand Name: PERFORM REV INSERT SZ 1/2 36MM DIA +3 10 DG
• 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: 20426066
• Report Number: 0001649390-2024-00584
• Device Sequence Number: 7589497
• Product Code: PHX
• UDI-Device Identifier: 00846832084760
• UDI-Public: 00846832084760
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/09/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWR1363
• Device Lot Number: AE3292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2022
• 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: 89 YR
• Patient Sex: Female
• Patient Weight: 46 KG