MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 3/4 42MM DIA +0 10 DG RET; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWR4420
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The ansm reported the following event: "unable to fully impact the 10° retentive insert, there was a persistent "gap" between the insert and the perform stem.On removal, it became apparent that the metal ring had shifted to the right.During the impaction procedure.What measures/actions were taken to complete the procedure? the surgeon changed the humeral stem (from a 4-short stem to a 4+-long stem) and the insert (from a 10° retentive ¾ 0 insert to a symmetrical retentive ¾ 0 insert).".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
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 device is returned or any further information is provided the investigation report will be reassessed.
Event or Problem Description
The ansm reported the following event: "unable to fully impact the 10° retentive insert, there was a persistent "gap" between the insert and the perform stem.On removal, it became apparent that the metal ring had shifted to the right.During the impaction procedure.What measures/actions were taken to complete the procedure? the surgeon changed the humeral stem (from a 4-short stem to a 4+-long stem) and the insert (from a 10° retentive ¾ 0 insert to a symmetrical retentive ¾ 0 insert).".

• Brand Name: PERFORM REV INSERT SZ 3/4 42MM DIA +0 10 DG 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: 19774342
• Report Number: 0001649390-2024-00327
• Device Sequence Number: 8332416
• Product Code: PHX
• UDI-Device Identifier: 00846832085057
• UDI-Public: 00846832085057
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DWR4420
• Device Lot Number: AF4461
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2023
• 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
• Patient Sex: Unknown