MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 32IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121932150
Medical Device Problem Codes	Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/15/2025
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during the procedure of right hip endoprosthesis, pinnacle, pinnacle marathon orac ceramic head biolox delta was implanted.The course of the operation and rehabilitation was uncomplicated.Control x-rays were performed - endoprosthesis elements healed without any signs of loosening, patient functioned well until (b)(6) 2025, when during walking there was damage to the polyethylene insert.From that moment on, the patient felt the creaking and aching of the right hip.On (b)(6) 2025 the revision procedure was performed and the damaged insert and head were replaced.
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 hat 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 corrected: h6 (medical device problem code) pe code implant noise: audible sound was removed.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 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: d9.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: physician reported: during the procedure of right hip endoprosthesis (b)(6), pinnacle, pinnacle marathon orac ceramic head biolox delta was implanted.The course of the operation and rehabilitation was uncomplicated.Control x-rays were performed - endoprosthesis elements healed without any signs of loosening, patient functioned well until (b)(6) 2025, when during walking there was damage to the polyethylene insert.From that moment on, the patient felt the creaking and aching of the right hip.On (b)(6) 2025 the inspection procedure was performed- the damaged insert and head were replaced.The product was not returned to depuy synthes, however a photo was provided for review.The photo investigation revealed that the pinn mar +4 10d 32idx50od was covered with blood remnants.Additionally, it was noted that a large portion of the rim is 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.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 jx1634 number, and no non-conformances were identified during manufacturing.The overall complaint was confirmed as the observed condition of the pinn mar +4 10d 32idx50od 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 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 jx1634 number, and no non-conformances were identified during manufacturing.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: physician reported: during the procedure of right hip endoprosthesis 20.02.2023r, pinnacle, pinnacle marathon orac ceramic head biolox delta was implanted.The course of the operation and rehabilitation was uncomplicated.Control x-rays were performed - endoprosthesis elements healed without any signs of loosening, patient functioned well until (b)(6) 2025, when during walking there was damage to the polyethylene insert.From that moment on, the patient felt the creaking and aching of the right hip.On (b)(6) 2025 the inspection procedure was performed- the damaged insert and head were replaced.The product was not returned to depuy synthes; however, a photo was provided for review.See attachment "picture 1".The photo investigation revealed that the pinn mar +4 10d 32idx50od was covered with blood remnants.Additionally, it was noted that a large portion of the rim is 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.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 jx1634 number, and no non-conformances were identified during manufacturing.The overall complaint was confirmed as the observed condition of the pinn mar +4 10d 32idx50od 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 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 jx1634 number, and no non-conformances were identified during manufacturing.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, " physician reported: during the procedure of right hip endoprosthesis (b)(6) 2023r , pinnacle, pinnacle marathon orac ceramic head biolox delta was implanted.The course of the operation and rehabilitation was uncomplicated.Control x-rays were performed - endoprosthesis elements healed without any signs of loosening, patient functioned well until (b)(6) 2025, when during walking there was damage to the polyethylene insert.From that moment on, the patient felt the creaking and aching of the right hip.On (b)(6) 2025 the inspection procedure was performed- the damaged insert and head were replaced." the product was returned to depuy synthes for evaluation.Visual inspection of the returned device did found that the pinn mar +4 10d 32idx50od had the rim fractured.In addition the rim has 5 of the 6 anti-rotation device (ard) tabs fractured.The pinn mar +4 10d 32idx50od 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).Based on the observed conditions of the pinn mar +4 10d 32idx50od and the ceramic head it is reasonable to conclude that a disassociation event occurred.The fractured fragments were not returned for evaluation.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 jx1634 number, and no non-conformances were identified during manufacturing.The overall complaint was confirmed as the observed condition of the pinn mar +4 10d 32idx50od 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 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: a manufacturing record evaluation was performed for the finished device jx1634 number, and no non-conformances were identified during manufacturing.Corrected: h3.

• Brand Name: PINN MAR +4 10D 32IDX50OD
• 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: 23031589
• Report Number: 1818910-2025-15766
• Device Sequence Number: 9181506
• Product Code: LPH
• UDI-Device Identifier: 10603295014041
• UDI-Public: (01)10603295014041(17)270531(10)JX1634
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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,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: 121932150
• Device Lot Number: JX1634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 11/10/2025; 11/21/2025; 11/25/2025; 12/03/2025; 02/23/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/12/2025; 11/21/2025; 11/26/2025; 12/17/2025; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• 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 +5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown