MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 3/4, 42MM DIA, +3; SHOULDER, PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWP2423
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient showed up to clinic and was unstable.There will be a possible revision due to subluxations.
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.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 on a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Patient showed up to clinic and was unstable.There will be a possible revision due to subluxations.

• Brand Name: PERFORM REV INSERT SZ 3/4, 42MM DIA, +3
• 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 MN NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15205074
• Report Number: 0001649390-2022-00049
• Device Sequence Number: 1856326
• Product Code: PHX
• UDI-Device Identifier: 00846832084524
• UDI-Public: 00846832084524
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 11/12/2025
• Device Model Number: DWP2423
• Device Catalogue Number: DWP2423
• Device Lot Number: 1394AW007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• 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 Sex: Unknown