MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2 39MM DIA +3; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP1393
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Insert dislocated forward.Revision surgery is planned.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Insert dislocated forward.Revision surgery is planned.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned and x-ray was provided for evaluation and matches the alleged failure mode.The device inspection revealed the following: the returned device was visually inspected and reveals little marking on the surface that could be a result from grasping the polyethylene insert with some kind of forceps to get it out of the soft tissues during extraction phase of the revision surgery.Furthermore, medical expert opinion reveals, the x ray confirm dissociation and migration of the polyethylene insert of the perform humeral reverse tray.Since there are images in ap direction only, the direction of the component migration cannot be determined with certainty.The device was functionally inspected with a test fixture.Initially, using hand pressure to adequately set in the test fixture.After using a mallet and impact tool to apply three impacts, the device was properly set and could not be pulled out with hand pressure.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.Based on investigation, the root cause was attributed to a user related issue.The returned device functioned as intended.It is possible failure was caused due to the surgeon failed to follow the technique which states to apply hand pressure first before impaction.This could lead to misalignment of the insert leading to the issue noted in this complaint.If any further information is provided, the complaint report will be updated.

• Brand Name: PERFORM REV INSERT SZ 1/2 39MM DIA +3
• 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: 19929421
• Report Number: 0001649390-2024-00354
• Device Sequence Number: 14137261
• Product Code: PHX
• UDI-Device Identifier: 00846832084432
• UDI-Public: (01)00846832084432(11)230420(17)280420(21)6373AY045
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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 Catalogue Number: DWP1393
• Device Lot Number: 6373AY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian