MAUDE Adverse Event Report: TORNIER S.A.S. PERFORM REV INSERT SZ 3/4, 39MM DIA, +6 RET; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWP4396
Medical Device Problem Codes	Component Missing (2306); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device retained by hospital.
Event or Problem Description
The patient had to come back in less than a week after their initial surgery to have a revision surgery to have the disassociated reversed insert explanted and a new one implanted.Upon getting into the revision surgery, the poly had indeed disassociated from the humeral stem and there appeared to be no locking ring inside of the poly.
Additional Manufacturer Narrative
The reported event was not confirmed.The device was not returned for evaluation and no other evidence was provided.The device inspection was not possible as the product was not returned for investigation and no other evidence was provided.A review of the labeling and 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.More detailed information as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The patient had to come back in less than a week after their initial surgery to have a revision surgery to have the disassociated reversed insert explanted and a new one implanted.Upon getting into the revision surgery, the poly had indeed disassociated from the humeral stem and there appeared to be no locking ring inside of the poly.

• Brand Name: PERFORM REV INSERT SZ 3/4, 39MM DIA, +6 RET
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• 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: 16550434
• Report Number: 0001649390-2023-00032
• Device Sequence Number: 6042485
• Product Code: PHX
• UDI-Device Identifier: 00846832084685
• UDI-Public: 00846832084685
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DWP4396
• Device Catalogue Number: DWP4396
• Device Lot Number: 3600AW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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 Age: 75 YR
• Patient Sex: Male