MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 32IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121932058
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2025
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.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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 had a hip surgery and came back after 8 weeks because the liner had luxaded out of the cup.Patient was revised.
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 d4 (expiration date), d9, d10 (concomitant).Corrected: d4 (primary udi).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 provided: "patient that had a hip surgery and came back after 8 weeks because the liner had luxaded out of the cup".The product was returned to depuy synthes for evaluation.Visual inspection of the returned device revealed four (4) of the six (6) anti-rotation device (ard) tabs fractured/shredded, the device rim scratched and the edge of the device slightly deformed.Device had signs of being implanted for a period of time; and the x-ray evidence revealed the delta cer head 12/14 32mm +5 (head) not centered at the implant site, condition that confirms a disassociation between the pinn mar neut 32idx58od (liner) and the pinn 100 w/gription 58mm (cup).Based on the evidence provided, the liner appeared to have been edge loaded causing eccentric wear/deformation in the rim of the device and ultimately contributing to the failure of the anti-rotation devices (ards), allowing for the liner to disassociated from the 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, patient changes over time and the extraction process.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 dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was unable to be performed due to the post-manufacturing damage.A manufacturing record evaluation was performed for the finished device 3902301 lot number, and four non-conformances were identified, however not related to the reported failure mode of the complaint.The overall complaint was confirmed as the observed condition of the pinn mar neut 32idx58od 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 3902301 lot number, and four non-conformances were identified, however not related to the reported failure mode of the complaint.Corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary according to the information provided: "patient that had a hip surgery and came back after 8 weeks because the liner had luxaded out of the cup".The product was not returned to depuy synthes; however, photos were provided for review.The photo/x-ray investigation revealed four (4) of the six (6) anti-rotation device (ard) tabs fractured/shredded, the device rim scratched and the edge of the device slightly deformed.Device had signs of being implanted for a period of time; and the x-ray evidence revealed the delta cer head 12/14 36mm +12 (head) not centered at the implant site, condition that confirms a disassociation between the pinn mar neut 32idx58od (liner) and the pinn 100 w/gription 58mm (cup).Based on the evidence provided, the liner appeared to have been edge loaded causing eccentric wear/deformation in the rim of the device and ultimately contributing to the failure of the anti-rotation devices (ards), allowing for the liner to disassociated from the 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, patient changes over time and the extraction process.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 3902301 lot number, and four non-conformances were identified, however not related to the reported failure mode of the complaint.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the pinn mar neut 32idx58od 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 3902301 lot number, and four non-conformances were identified, however not related to the reported failure mode of the complaint.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided: "patient that had a hip surgery and came back after 8 weeks because the liner had luxaded out of the cup".The product was not returned to depuy synthes; however, photos were provided for review.The photo/x-ray investigation revealed four (4) of the six (6) anti-rotation device (ard) tabs fractured/shredded, the device rim scratched and the edge of the device slightly deformed.Device had signs of being implanted for a period of time; and the x-ray evidence revealed the delta cer head 12/14 32mm +5 (head) not centered at the implant site, condition that confirms a disassociation between the pinn mar neut 32idx58od (liner) and the pinn 100 w/gription 58mm (cup).Based on the evidence provided, the liner appeared to have been edge loaded causing eccentric wear/deformation in the rim of the device and ultimately contributing to the failure of the anti-rotation devices (ards), allowing for the liner to disassociated from the 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, patient changes over time and the extraction process.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 3902301 lot number, and four non-conformance were identified, however not related to the reported failure mode of the complaint.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the pinn mar neut 32idx58od 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 3902301 lot number, and four non-conformances were identified, however not related to the reported failure mode of the complaint.

• Brand Name: PINN MAR NEUT 32IDX58OD
• 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: 23623827
• Report Number: 1818910-2025-20589
• Device Sequence Number: 8977160
• Product Code: LPH
• UDI-Device Identifier: 10603295013938
• UDI-Public: (01)10603295013938(17)270731(10)3902301
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 121932058
• Device Lot Number: 3902301
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 01/26/2026; 02/11/2026; 02/25/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/07/2026; 01/28/2026; 02/12/2026; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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 36MM +12; PINN 100 W/GRIPTION 58MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown