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	Naturally Worn (2988); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 narrative: h3, h6: a manufacturing record evaluation was performed for the finished device (b)(6), and no non-conformances/manufacturing irregularities related to the complaint condition were identified.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device did find that the pinn mar neut 32idx54od had the rim fractured.In addition, the rim has 3 of the 6 anti-rotation device (ard) tabs fractured.The pinn mar neut 32idx54od appeared to have been edge loaded as well, causing eccentric deformation in the rim of the device and contributing to the failure of the anti-rotation devices (ards).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.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.A manufacturing record evaluation was performed for the finished device (b)(6), and no non-conformances/manufacturing irregularities related to the complaint condition were identified.The overall complaint was confirmed as the observed condition of the pinn mar neut 32idx54od would have contributed to a device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.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.
Event or Problem Description
Broken ceramic hip head.
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.H11 additional narrative: added: d10 concomitant.Corrected: h6 (health effect-impact code), h6 (medical device problem code) updated from undetermined allegation to (implant bearing wear) polyethylene 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: broken ceramic hip head.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device did found that the pinn mar neut 32idx54od had the rim fractured.In addition the rim has 3 of the 6 anti-rotation device (ard) tabs fractured.The pinn mar neut 32idx54od appeared to have been edge loaded as well, causing eccentric deformation in the rim of the device and contributing to the failure of the anti-rotation devices (ards).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.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.A manufacturing record evaluation was performed for the finished device 4091666 number, and no non-conformances / manufacturing irregularities related to the complaint condition were identified.The overall complaint was confirmed as the observed condition of the pinn mar neut 32idx54od would have contributed to a device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.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: 1) quantity manufactured: (b)(4).2) date of manufacture: 26-feb-2023.3) any anomalies or deviations identified in dhr: no related.4) expiry date: 31-jan-2028.5) ifu reference: 090200701.Device history review: a manufacturing record evaluation was performed for the finished device 4091666 number, and no non-conformances / manufacturing irregularities related to the complaint condition were identified.Corrected: h6 (medical device problem code).

• 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 Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24416433
• Report Number: 1818910-2026-03454
• Device Sequence Number: 5939748
• Product Code: LPH
• UDI-Device Identifier: 10603295013914
• UDI-Public: (01)10603295013914(17)280131(10)4091666
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121932054
• Device Lot Number: 4091666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 02/24/2026; 03/04/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/02/2026; 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2023
• 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: UNK HIP FEMORAL HEAD CERAMIC.
• Patient Sex: Unknown