MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 32IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121932054
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient who had received successful total hip arthroplasty surgery presented with hip pain and audible squeaking after reportedly falling out of bed.X-rays were taken appeared to show a presumptive liner dissociation.Revision surgery was performed which confirmed that the marathon 32/54 neutral liner had dissociated from the pinnacle 54mm sector gription shell.The 32 +1 ceramic femoral head had sustained damage in the form of stripe wear and was explanted.The dissociated liner was damaged and a couple of fragments had broken off.The liner and the two fragments were successfully explanted.After inspecting the shell, there appeared to be some damage to one side of the interior of the shell.The shell was subsequently explanted.Surgeon proceeded to ream the acetabulum up to size 55mm and then implant a 56mm sector gription shell, followed by a 36/54 neutral altrx liner, and finally a 36mm +1.5mm femoral head.Hip was reduced and surgery was completed successfully.No additional information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).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: a patient who had received successful total hip arthroplasty surgery in (removed), presented with hip pain and audible squeaking after reportedly falling out of bed in late (removed).X-rays were taken appeared to show a presumptive liner dissociation.Revision surgery was performed on (removed) which confirmed that the marathon 32/54 neutral liner (ref: 121932054, lot: j62c26) had dissociated from the pinnacle 54mm sector gription shell (ref: 121732054, lot: 9003441).The 32 +1 ceramic femoral head (ref: 136532310, lot: 9170894) had sustained damage in the form of stripe wear and was explanted.The dissociated liner was damaged and a couple of fragments had broken off.The liner and the two fragments were successfully explanted.After inspecting the shell, there appeared to be some damage to one side of the interior of the shell.The shell was subsequently explanted.Surgeon proceeded to ream the acetabulum up to size 55mm and then implant a 56mm sector gription shell (121732056), followed by a 36/54 neutral altrx liner (122136054), and finally a 36mm +1.5mm femoral head (136551000) hip was reduced and surgery was completed successfully.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the liner appears to have some anti-rotation device (ard) tabs sheared off.Based on the observations it is reasonable to consider that a dissociation event occurred between the liner and the cup.Additionally, a portion of the rim has fractured.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may influence eccentric loading.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.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the pinn mar neut 32idx54od would contribute to the reported condition.Based on the investigation findings, the potential cause is traced to component failure, and 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 activities.Device history lot: a manufacturing record evaluation was performed for the finished device [121932054/j62c26] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review: a manufacturing record evaluation was performed for the finished device [121932054/j62c26] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: PINN MAR NEUT 32IDX54OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19721114
• Report Number: 1818910-2024-15036
• Device Sequence Number: 12834681
• Product Code: LPH
• UDI-Device Identifier: 10603295013914
• UDI-Public: (01)10603295013914(17)241130(10)J62C26
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 07/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: 121932054
• Device Lot Number: J62C26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2019
• 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: DELTA CER HEAD 12/14 32MM +1; PINN SECTOR W/GRIPTION 54MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown