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

Catalog Number	DWP2420
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Laxity (4526); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
There was a revision of a tornier product, specifically a perform reverse glenoid with a perform humeral stem.The baseplate and stem were not removed but were adjusted by lateralizing the glenoid sphere.A spacer and a new poly component were used on the humeral side.The revision was necessary due to inadequate tensioning in the initial procedure.An update confirmed that the revision was successful, and it involved changing a standard glenosphere for a lateralized one and building up the poly component on the humeral side.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device disposition is unknown.
Event or Problem Description
There was a revision of a tornier product, specifically a perform reverse glenoid with a perform humeral stem.The baseplate and stem were not removed but were adjusted by lateralizing the glenoid sphere.A spacer and a new poly component were used on the humeral side.The revision was necessary due to inadequate tensioning in the initial procedure.An update confirmed that the revision was successful, and it involved changing a standard glenosphere for a lateralized one and building up the poly component on the humeral side.
Additional Manufacturer Narrative
Please note the corrections made to the device code, clinical signs code, and health impact code: the reported event was not confirmed, since the device was not returned for evaluation and no other evidences 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.

• Brand Name: PERFORM REV INSERT SZ 3/4, 42MM DIA, +0
• 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: 17718466
• Report Number: 0001649390-2023-00228
• Device Sequence Number: 7176661
• Product Code: PHX
• UDI-Device Identifier: 00846832084517
• UDI-Public: 00846832084517
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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 Expiration Date: 09/12/2026
• Device Catalogue Number: DWP2420
• Device Lot Number: 2801AX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2021
• 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