MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121732058
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: this is the second revision of this acetabulum; the first procedure was reported with (b)(4).The polyethylene liner became dissociated from the pinnacle sector cup in that instance, and the same has happened here.There is thought that there may be something wrong with the interface between the liner and the cup.I have requested that the liner and cup be decontaminated and available to be sent for inspection.The sector cup was explanted and revised with a pinnacle multihole cup and 40mm liner.The product was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the pinn sector w/gription 58mm has signs of organic material adhered to the outer fixation surface.Additionally signs of metal wear were observed at the articulating surface most likely caused by being in contact with the femoral head.Based on this finding and the observations of the returned liner it is reasonable to conclude that a disassociation event occurred between the liner and the acetabular cup.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the acetabular cup failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may contributed.Consideration must be given to all potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.A manufacturing record evaluation was performed for the finished device [121732058/4093082] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the pinn sector w/gription 58mm would have contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activitie.Device history lot: a manufacturing record evaluation was performed for the finished device [121732058/4093082] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review: a manufacturing record evaluation was performed for the finished device [121732058/4093082] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.
Event or Problem Description
This is the second revision of this acetabulum, the first procedure was reported with (b)(4).The polyethylene liner became dissociated from the pinnacle sector cup in that instance, and the same has happened here.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: corrected: d4 primary udi number if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINN SECTOR W/GRIPTION 58MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19742691
• Report Number: 1818910-2024-15179
• Device Sequence Number: 12692682
• Product Code: KWA
• UDI-Device Identifier: 10603295010333
• UDI-Public: (01)10603295010333(10)4093082
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K093646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/15/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 121732058
• Device Lot Number: 4093082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 08/07/2024; 09/18/2024; 09/24/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/12/2024; 09/19/2024; 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DLT TS CER HD 12/14 36MM +8.5; PINN MAR NEUT 36IDX58OD; UNK HIP FEMORAL HEAD CERAMIC; UNKNOWN HIP ACETABULAR LINERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male