MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 3/4 39MM DIA +3; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWP2393

Device Problems Detachment of Device or Device Component (2907); Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

An issue has been reported with a perform humeral poly implant where the lock ring was assembled upside down during manufacturing, leading to disassembly from the patient in the recovery room.Immediate action was taken, with the insert being removed and a new one implanted.The revision surgery was successful without additional adverse consequences to the patient.

Manufacturer Narrative

Correction: h6 clinial signs code: the reported event was confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the visual inspection of the returned device reveals that the orientation of the lock ring on the humeral poly component was incorrectly assembled in an up-side manner, and this was validated by the r&d member of r&d team.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, or design related problems were found during the investigation.The nature of the complaint does not necessitate an op-tech/ifu review since it is a manufacturing related issue.Based on investigation, the root cause was attributed to a manufacturing related issue.Therefore, an nc has been opened to investigate further and prevent the recurrence.If any further information is provided, the complaint report will be updated.

Event Description

An issue has been reported with a perform humeral poly implant where the lock ring was assembled upside down during manufacturing, leading to disassembly from the patient in the recovery room.Immediate action was taken, with the insert being removed and a new one implanted.The revision surgery was successful without additional adverse consequences to the patient.

• Brand Name: PERFORM REV INSERT SZ 3/4 39MM DIA +3
• Type of Device: 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: 18875665
• MDR Text Key: 337334820
• Report Number: 3000931034-2024-00099
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832084494
• UDI-Public: 00846832084494
• 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
• Report Date: 03/11/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWP2393
• Device Lot Number: 1495AY
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• 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