MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2, 36MM DIA, +3; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWP1363
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The poly became disassociated with the stem.We revised the patient, implanting a new stem spacer, and new poly.
Additional Manufacturer Narrative
The device is currently being returned.If additional information becomes available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction d4 lot, the reported event could not be confirmed.The device was returned for evaluation and functional testing could not confirm the alleged failure mode as the device was found to function as intended.The device inspection revealed the following: visual inspection: a visual inspection revealed the returned poly insert (dwp1363) exhibits a slightly deformed metal ring that circumvents the device.There are gouges and scratches to the poly as well.Discussions with the r&d engineer during review of similar previous complaints revealed, ¿the bent nature of the ring typically indicates that the device was impacted without first applying thumb pressure to the poly.This thumb pressure is prescribed per the technique and helps to center the locking ring.¿ functional inspection: a functional test was performed with the returned complaint device in our split fixture.The device seated in the fixture without issue by following the surgical technique 1-2 impactions after applying some thumb pressure to the returned device.A review of the device history for the reported lot did not indicate any abnormalities.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 analysis of the returned component and provided information, the root cause was attributed to a user related issue.The most likely cause of the reported difficulty is due to the user not applying thumb pressure to the polyethylene component prior to impaction.The surgical technique instructs the user to ¿apply hand pressure to begin to engage the locking mechanism.¿ if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The poly became disassocaited with the stem.We revised the patient, implanting a new stem spacer, and new poly.

• Brand Name: PERFORM REV INSERT SZ 1/2, 36MM DIA, +3
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13169112
• Report Number: 3004983210-2022-00002
• Device Sequence Number: 12124361
• Product Code: PHX
• UDI-Device Identifier: 00846832084401
• UDI-Public: 00846832084401
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/17/2025
• Device Model Number: DWP1363
• Device Catalogue Number: DWP1363
• Device Lot Number: AD3691007
• 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: 12/07/2021
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female