MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 28IDX44OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121928144
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Joint Laxity (4526)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the patient had undergone a thr surgery in (b)(6) 2024 and within 1 year patient had to come back to the surgeon on account of complaint of severe pain.Upon x-ray examination it was found that the liner has been dislocated.Liner dissociation is a problem with pinnacle cup.This is a serious problem causing catastrophic poly wear, metallosis and instability.Revision surgery within one year.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: patient had undergone a thr surgery in (b)(6) 2024 and within 1 year patient had to come back to the surgeon on account of complaint of severe pain.Upon x-ray examination it was found that the liner has been dislocated.Liner dissociation is a problem with pinnacle cup.This is a serious problem causing catastrophic poly wear, metallosis and instability.Redo surgery within one year, that is supposed to last 20 to 25 years, is not acceptable at any cost.Please don¿t charge for this patient.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment: re_ pinnacle liner dissociation.The x-ray investigation revealed that a disassociation occurred between the acetabular liner and the cup.The femoral head appears to be not centrally loaded since it can be observed that it is having a direct contact with the cup.Additionally, signs of fracture and wear were observed on the liner, consistent with a disassociation event.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.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.A manufacturing record evaluation was performed for the finished device product description: pinn mar +4 10d 28idx44od product code: 121928144 lot number: m5031z and no non-conformances or manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the pinn mar +4 10d 28idx44od would have contributed 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 complaint condition.As part of j&j medtech orthopaedics 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 product description: pinn mar +4 10d 28idx44od product code: 121928144 lot number: m5031z and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: pinn mar +4 10d 28idx44od product code: 121928144 lot number: m5031z and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: added: d10 (concomitant).

• Brand Name: PINN MAR +4 10D 28IDX44OD
• 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 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22588544
• Report Number: 1818910-2025-12817
• Device Sequence Number: 17278192
• Product Code: LPH
• UDI-Device Identifier: 10603295013433
• UDI-Public: (01)10603295013433(17)281031(10)M5031Z
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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

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: 121928144
• Device Lot Number: M5031Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• 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: UNKNOWN HIP ACETABULAR CUP.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown