MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 32IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122132052
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient started to experience ¿squeaking¿ noises.No incident occurred.Upon x-ray surgeon found poly liner unengaged.Liner included was removed one screw and 32+ 5 bio ceramic head.Patient required a revision surgery.
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : patient started to experience ¿ squeaking¿ noises.Says no incident occurred.Upon xray dr found poly liner unengaged.Tried adding attachments but having issues.Liner included was removed one screw and 32+ 5 bio ceramic head.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.(b)(4).The x-ray investigation revealed that the ceramic head is not centrally loaded therefore it is reasonable to conclude that a disassociation event occurred between the acetabular liner and the cup.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.The overall complaint was confirmed as the observed condition of the altrx neut 32idx52od 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 reported 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 records evaluation (mre) was not performed as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.H11 additional narrative: added: d10 (concomitant).

• Brand Name: ALTRX NEUT 32IDX52OD
• 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 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22331052
• Report Number: 1818910-2025-10564
• Device Sequence Number: 21170848
• Product Code: LPH
• UDI-Device Identifier: 10603295016113
• UDI-Public: (01)10603295016113
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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: 122132052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNK HIP BONE SCREW; UNK HIP FEMORAL HEAD CERAMIC; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Unknown