MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 3/4, 42MM DIA, +6, 10 DEG RET; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWR4426
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary reverse shoulder arthroplasty around 2020/21.The patient had a revision for instability on (b)(6) 2021 and again on (b)(6) 2022.The patient was chopping wood and carrying the wood in his affected arm.The patient experienced a dislocation on (b)(6) 2023.X-rays were taken at his local va and it was evident that the polyethylene liner had disassociated.The patient underwent surgery on (b)(6) 2023 to remove the old liner and spacer and replace with new items.
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 on a supplemental report.

• Brand Name: PERFORM REV INSERT SZ 3/4, 42MM DIA, +6, 10 DEG RET
• 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: 16765666
• Report Number: 0001649390-2023-00062
• Device Sequence Number: 16910107
• Product Code: PHX
• UDI-Device Identifier: 00846832085071
• UDI-Public: 00846832085071
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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 Model Number: DWR4426
• Device Catalogue Number: DWR4426
• Device Lot Number: AC9366049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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