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 Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pe inlay has dislocated from the acetabular component.This affected the left hip joint.
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.H11 additional manufacturer narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
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: d10 (concomitant).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: d4 (expiry date), d9, d10 (concomitant).Corrected: d4 (primary udi number).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, "hcp is reporting to nca/bfarm: "the pe inlay has dislocated from the acetabular component.(primary implantation [redacted])".The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device did found that the pinn mar neut 32idx52od shows signs of fracture.In addition the rim of the pinn mar neut 32idx52od has 4 of the 6 anti-rotation device (ard) tabs fractured.The fractured fragments were not returned for evaluation.Significant metal transfer onto the ceramic femoral head was observed, suggesting that disassociation of the liner and cup occurred after the liner fractured which would have compromised the locking mechanism.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.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 121932052 lot number 9485148, and no non-conformances / manufacturing irregularities were identified during manufacturing.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 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.: 1) quantity manufactured: (b)(4) pcs total manufactured 2) date of manufacture: 4/26/2020.3) any anomalies or deviations identified in dhr: none.4) expiry date: 3/21/2025.5) ifu reference: 090200701.Device history review : 1) quantity manufactured: (b)(4) pcs total manufactured 2) date of manufacture: 4/26/2020.3) any anomalies or deviations identified in dhr: none.4) expiry date: 3/21/2025.5) ifu reference: 090200701.H11 additional narrative: corrected: h3.

• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22588358
• Report Number: 1818910-2025-12808
• Device Sequence Number: 9392842
• Product Code: LPH
• UDI-Device Identifier: 10603295013907
• UDI-Public: (01)10603295013907(17)250331(10)9485148
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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

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 Expiration Date: 03/31/2025
• Device Catalogue Number: 121932052
• Device Lot Number: 9485148
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 07/31/2025; 07/31/2025; 09/29/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/01/2025; 08/01/2025; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2020
• 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 ADEPT.; UNKNOWN HIP FEMORAL HEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male