MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 32IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121932052
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2025
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 pinnacle liner was revised due to luxation out of the pinnacle cup.One piece has broken off.Head has been articulating against the cup floor.
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: b5, d4 (expiry date), d10 (concomitant).Corrected: d4 (primary udi number).Recaptured codes on h6 (medical device problem code).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
Additional information received: a.Were the head and/or cup showing signs of wear? - yes, but after the liner had dislocated.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: pinnacle liner which is revised due to luxation out of the pinnacle cup.One piece has broken off.Head [product code removed] has been articulating against the cup floor.(shown in picture attached).The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that 3 out of the 6 four anti-rotation device (ard) tabs sheared off of the pinn mar neut 32idx52od.Additionally, the liner appeared to have been edge loaded causing eccentric deformation in the rim of the device and ultimately contributing to the failure of the anti-rotation devices (ards).There are machining lines from the manufacturing process yet visible within the liner which would not be as obviously present if would be more centrally loaded.Furthermore the rim presents a small portion fractured.Not all the fractured fragments were returned for evaluation.Also scratches were identified at the surface of the liner most likely caused by the explantation process.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.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 description: pinn mar neut 32idx52od product code: 121932052 lot number: 3733676 and no non-conformances or manufacturing irregularities that would contribute to the reported complaint were identified.The overall complaint was confirmed as the observed condition of the pinn mar neut 32idx52od 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 product description: pinn mar neut 32idx52od product code: 121932052 lot number: 3733676 and no non-conformances or manufacturing irregularities that would contribute to the reported complaint were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: pinn mar neut 32idx52od product code: 121932052 lot number: 3733676 and no non-conformances or manufacturing irregularities that would contribute to the reported complaint were identified.H11 additional narrative: corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: pinnacle liner which is revised due to luxation out of the pinnacle cup.One piece has broken off.Head [product code removed] has been articulating against the cup floor.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the pinn mar neut 32idx52od has a portion of the rim fractured.Based on the observations of the altrx neut 36idx64od and the delta cer head 12/14 32mm +9, it is suspected to conclude that a disassociation event occurred between the liner and 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.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.The overall complaint was confirmed as the observed condition of the pinn mar neut 32idx52od 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 product description: pinn mar neut 32idx52od product code: 121932052 lot number: 3733676 and no non-conformances or manufacturing irregularities that would contribute to the reported complaint were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: pinn mar neut 32idx52od product code: 121932052 lot number: 3733676 and no non-conformances or manufacturing irregularities that would contribute to the reported complaint were identified.

• Brand Name: PINN MAR NEUT 32IDX52OD
• 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): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23546987
• Report Number: 1818910-2025-19784
• Device Sequence Number: 15773838
• Product Code: LPH
• UDI-Device Identifier: 10603295013907
• UDI-Public: (01)10603295013907(17)270331(10)3733676
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K001534
• 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,Distributor
• Initial Reporter Occupation: Physician
• 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: 121932052
• Device Lot Number: 3733676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 01/20/2026; 01/20/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 11/26/2025; 01/20/2026; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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 +9; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown