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

Device Problems Component Missing (2306); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 02/16/2023

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 311368556
• Report Number: 0001649390-2023-00032
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832084685
• UDI-Public: 00846832084685
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Male