MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 28IDX46OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121928146
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2024
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
Patient had surgery 1 year ago and had to be re-intervened because the polyethylene insert split.The pinnacle cup and polyethylene insert were removed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, ¿patient had surgery 1 year ago and had to be re-intervened because the polyethylene insert split.The pinnacle cup and polyethylene insert were removed".The product was not returned to depuy synthes, however photos were provided for review.(b)(6).Visual analysis of the photo revealed that the rim of the pinn mar +4 10d 28idx46od appears to have two (2) anti-rotation devices (ards) broken off.A fracture was also observed on the lipped section of the liner.It is worth mentioning that a ceramic head with sign of what appears to be metal transfer can be seen in the provided photos.Based on the available evidence, it is reasonable to concluded that the pinn mar +4 10d 28idx46od disassociated from the acetabular 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 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.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 [121928146 / jw9052] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The overall complaint was confirmed as the observed condition of the pinn mar +4 10d 28idx46od would contribute to the complained device issue.Based on the investigation findings, a potential cause is traced to component failure.No corrective and/or preventative action is proposed.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 [121928146 / jw9052] number, and no non-conformances / manufacturing irregularities related to the malfunction 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.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: h6 (problem code).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 according to the information received, ¿patient had surgery 1 year ago and had to be re-intervened because the polyethylene insert split.The pinnacle cup and polyethylene insert were removed.¿ the pinn mar +4 10d 28idx46od (lot.Jw9052) returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis revealed that a portion of the lipped section of the liner was fractured; fragment was returned for evaluation.Additionally, three (3) out of four (4) anti-rotation devices (ards) tabs of the locking mechanism were found sheared off; fragments were not returned.Signs of deformation were also observed all over the bottom rim of the liner.Based on the observed condition of the device along with the involved implants; it is reasonable to conclude that a disassociation event occurred between the liner and the acetabular cup.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner locking mechanism 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.A manufacturing record evaluation was performed for the finished device [121928146 / jw9052] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The overall complaint was confirmed as the observed condition of the pinn mar +4 10d 28idx46od would contribute 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 [121928146 / jw9052] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.Device history review a manufacturing record evaluation was performed for the finished device [121928146 / jw9052] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.Corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, ¿patient had surgery 1 year ago and had to be re-intervened because the polyethylene insert split.The pinnacle cup and polyethylene insert were removed".The product was not returned to depuy synthes, however photos were provided for review."source file - novedad por calidad pcte (b)(6) fsfb", "imagen (7)" , "imagen (6)", "imagen (5)" and "imagen (4)" visual analysis of the photo revealed that the rim of the pinn mar +4 10d 28idx46od appears to have two (2) anti-rotation devices (ards) broken off.A fracture was also observed on the lipped section of the liner.It is worth mentioning that a ceramic head with sign of what appears to be metal transfer can be seen in the provided photos.Based on the available evidence, it is reasonable to concluded that the pinn mar +4 10d 28idx46od disassociated from the acetabular 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 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.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 [121928146 / jw9052] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.The overall complaint was confirmed as the observed condition of the pinn mar +4 10d 28idx46od would contribute to the complained device issue.Based on the investigation findings, a potential cause is traced to component failure.No corrective and/or preventative action is proposed.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 [121928146 / jw9052] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.Corrected: h3.

• Brand Name: PINN MAR +4 10D 28IDX46OD
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18799855
• Report Number: 1818910-2024-04699
• Device Sequence Number: 15281453
• Product Code: LPH
• UDI-Device Identifier: 10603295013440
• UDI-Public: 10603295013440
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 02/28/2024

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: 121928146
• Device Lot Number: JW9052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 03/28/2024; 11/04/2025; 03/04/2026; 03/06/2026; 03/13/2026
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/01/2024; 11/13/2025; 03/06/2026; 03/11/2026; 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• 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: UNK HIP ACETABULAR CUP PINNACLE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown