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

Catalog Number	122132150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > according to the information received, "i wish to report an incident of implant failure.Some back story to this incident.Patient underwent a primary thr using pinnacle corail roughly 12 months ago in hospital.Revision of poly and femoral head on (b)(6) 2025.Primary hip was replaced using the following implants below.Pinnacle gription sector cup size 50, screws x 2, 32 id 50 od +4 10 altrx liner, size 11 kla stem and 32 +1 ceramic head.Revised (b)(6) 2025 with the following implants below.Size 50 od 32 id neutral altrx liner, 32 + 9 ceramic delta ts head".The photo investigation revealed that the altrx +4 10d 32idx50od has a portion of the rim fractured in 4 pieces.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 device failure.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 manufacturing record evaluation was performed for the finished device product code 122132150 lot number m4858f, and no non-conformances / manufacturing irregularities were identified during manufacturing.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 +4 10d 32idx50od would have contributed to the complained 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 record evaluation was performed for the finished device product code 122132150 lot number m4858f, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review = > a manufacturing record evaluation was performed for the finished device product code 122132150 lot number m4858f, and no non-conformances / manufacturing irregularities were identified during manufacturing.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "i wish to report an incident of implant failure.Some back story to this incident.Patient underwent a primary thr using pinnacle corail roughly 12 months ago in hospital.Revision of poly and femoral head on 30/06/25.Primary hip was replaced using the following implants below.Pinnacle gription sector cup size 50, screws x 2, 32 id 50 od +4 10 altrx liner, size 11 kla stem and 32 +1 ceramic head.Revised 30/06/25 with the following implants below.Size 50 od 32 id neutral altrx liner, 32 + 9 ceramic delta ts head".The photo investigation revealed that the altrx +4 10d 32idx50od has a portion of the rim fractured in 4 pieces.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 device failure.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 manufacturing record evaluation was performed for the finished device product code 122132150 lot number m4858f, and no non-conformances / manufacturing irregularities were identified during manufacturing.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 +4 10d 32idx50od would have contributed to the complained 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 record evaluation was performed for the finished device product code 122132150 lot number m4858f, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review: a manufacturing record evaluation was performed for the finished device product code 122132150 lot number m4858f, and no non-conformances / manufacturing irregularities were identified during manufacturing.
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 underwent a primary thr using pinnacle corail roughly 12 months ago.Revision of poly and femoral head occurred postoperatively.The liner was fractured.Implants were replaced with size 50 od 32 id neutral altrx liner, 32 + 9 ceramic delta ts head.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "i wish to report an incident of implant failure.Some back story to this incident.Patient underwent a primary thr using pinnacle corail roughly 12 months ago in hospital.Revision of poly and femoral head on (b)(6) 2025.Primary hip was replaced using the following implants below.Pinnacle gription sector cup size 50, screws x 2, 32 id 50 od +4 10 altrx liner, size 11 kla stem and 32 +1 ceramic head.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device did found the rim of the altrx +4 10d 32idx50od has 5 of the 6 anti-rotation device (ard) tabs fractured.The altrx +4 10d 32idx50od appeared to have been edge loaded as well, causing eccentric deformation of the device rim and contributing to the failure of the anti-rotation devices (ards).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 product code 122132150 lot number m4858f, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the altrx +4 10d 32idx50od would have contributed to the complained 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 record evaluation was performed for the finished device product code 122132150 lot number m4858f, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review: a manufacturing record evaluation was performed for the finished device product code 122132150 lot number m4858f, and no non-conformances / manufacturing irregularities were identified during manufacturing.Corrected: h3.

• Brand Name: ALTRX +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 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22628724
• Report Number: 1818910-2025-12993
• Device Sequence Number: 18410534
• Product Code: LPH
• UDI-Device Identifier: 10603295016168
• UDI-Public: (01)10603295016168(17)280930(10)M4858F
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

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: 122132150
• Device Lot Number: M4858F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 08/12/2025; 08/18/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/05/2025; 08/13/2025; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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: DELTA CER HEAD 12/14 32MM +1.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown