MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121731050
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Hcp is reporting to nca/bfarm: "patient with condition after cement-free hip prosthesis implantation in our clinic on (b)(6) 2023.Regular postoperative course.Representation on (b)(6) 2025 with new joint noises.Ct and x-ray diagnostics showed a suspected inlay dislocation.Revision surgery on (b)(6) 2025 revealed that the inlay was fractured and dislocated.".
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), h4.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).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.H10 additional narrative: added: d10.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: hcp is reporting to nca/bfarm: "patient with condition after cement-free hip prosthesis implantation in our clinic on (b)(6) 2023.Regular postoperative course.Representation on (b)(6) 2025, with new joint noises.Ct and x-ray diagnostics showed a suspected inlay dislocation.Revision surgery on (b)(6) 2025, revealed that the inlay was fractured and dislocated." the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the pinn 100 w/gription 50mm has signs of organic material and what appears to be bone ingrowth adhered to the outer fixation surface.Additionally signs of metal wear were observed at the articulating surface most likely caused by being in contact with the ceramic head.Based on the observations of the liner and ceramic head it is reasonable to conclude that a disassociation event occurred between the liner and the acetabular cup.However no signs of fracture were observed.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 description: pinn 100 w/gription 50mm product code: 121731050 lot number: 4121011 and no non-conformances or manufacturing irregularities were identified related to the failure mode of the complaint.The overall complaint was confirmed as the observed condition of the pinn 100 w/gription 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: 1) quantity manufactured: (b)(4).2) date of manufacture: 4/8/2023.3) any anomalies or deviations identified in dhr: 4 no non-conformances were found, however none of them were related to the failure mode of the complaint.4) expiry date: 03/31/2033.5) ifu reference: 090200701 rev t.

• Brand Name: PINN 100 W/GRIPTION 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21586289
• Report Number: 1818910-2025-03828
• Device Sequence Number: 9276231
• Product Code: KWA
• UDI-Device Identifier: 10603295010197
• UDI-Public: (01)10603295010197(17)330331(10)4121011
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090998
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/12/2025

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: 121731050
• Device Lot Number: 4121011
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 03/27/2025; 03/31/2025; 04/11/2025; 04/23/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/28/2025; 04/01/2025; 04/16/2025; 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2023
• 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.; ALTRX NEUT 32IDX50OD.; APEX HOLE ELIM POSITIVE STOP.; APEX HOLE ELIM POSITIVE STOP.; CORAIL2 LAT COXA VARA SIZE 12.; CORAIL2 LAT COXA VARA SIZE 12.; DELTA CER HEAD 12/14 32MM +1.; DELTA CER HEAD 12/14 32MM +1.; PINN 100 W/GRIPTION 50MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female