MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121722050
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/01/2025
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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient presented with hip pain and audible squeaking on movement postoperatively after a total hip replacement.Imaging showed eccentric femoral head position within the shell: suspicious for polyethylene liner wear or dissociation.There was no trauma.Stem appears well fixed.Revision was performed.
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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that 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.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: patient presented with hip pain and audible squeaking on movement.Imaging shows eccentric femoral head position within the shell ¿ suspicious for polyethylene liner wear or dissociation.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed signs of scratches on the edge of the cup consistent with the explantation process; however based on the observed condition of the ceramic head and the liner is reasonable to conclude that a disassociation event occurred between the liner and the acetabular cup.Therefore due to observed unintended interaction between the cup and the femoral head it is reasonable to conclude that the audible sound will be present.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other 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.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 code 121722050 lot number 9477187, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the pinnacle sector ii cup 50mm 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 121722050 lot number 9477187, 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 121722050 lot number 9477187, and no non-conformances / manufacturing irregularities were identified during manufacturing.H11 additional narrative: added: d10.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : patient presented with hip pain and audible squeaking on movement.Imaging shows eccentric femoral head position within the shell ¿ suspicious for polyethylene liner wear or dissociation.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.((b)(4)).The photo investigation revealed signs of scratches on the edge of the cup consistent with the explantation process; however based on the observed condition of the ceramic head and the liner is reasonable to conclude that a disassociation event occurred between the liner and the acetabular cup.Therefore due to observed unintended interaction between the cup and the femoral head it is reasonable to conclude that the audible sound will be present.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other 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.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 code 121722050 lot number 9477187, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the pinnacle sector ii cup 50mm 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 121722050 lot number 9477187, 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 121722050 lot number 9477187, and no non-conformances / manufacturing irregularities were identified during manufacturing.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary according to the information received, " patient presented with hip pain and audible squeaking on movement.Imaging shows eccentric femoral head position within the shell suspicious for polyethylene liner wear or dissociation.No trauma.Stem appears well fixed.Revision is planned.Will return any retrieved components if indicated." the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found signs of worn on the inner surface of the pinnacle sector ii cup 50mm, consistent with the ceramic head being in contact with this surface.It is not unreasonable to consider that an audible sound was generated due to the interaction between devices.Additionally, the edge of the device was deformed.Based on the observed condition of the cup, is reasonable to conclude that a disassociation occurred between the liner and the cup.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the cup is multi-factorial and consideration must be given to all other 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 121722050 lot number 9477187, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the pinnacle sector ii cup 50mm 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 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 121722050 lot number 9477187, 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 121722050 lot number 9477187, and no non-conformances / manufacturing irregularities were identified during manufacturing.H11 additional narrative: corrected: h3.

• Brand Name: PINNACLE SECTOR II CUP 50MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• 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: 22175402
• Report Number: 1818910-2025-09378
• Device Sequence Number: 20788104
• Product Code: LPH
• UDI-Device Identifier: 10603295009818
• UDI-Public: (01)10603295009818(17)300531(10)9477187
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P070026
• 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: Physician
• 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: 121722050
• Device Lot Number: 9477187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 06/23/2025; 06/25/2025; 06/27/2025; 07/01/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/18/2025; 06/24/2025; 06/26/2025; 06/30/2025; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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: ALTRX NEUT 32IDX50OD; DELTA CER HEAD 12/14 32MM +1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown