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

Catalog Number DWP2420

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Laxity (4526); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2023

Event Type  Injury  

Event 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 323042960
• Report Number: 0001649390-2023-00228
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832084517
• UDI-Public: 00846832084517
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWP2420
• Device Lot Number: 2801AX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention