MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121722050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Cup revision surgery after 10 years from implant.
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.
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.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.What is the affected side involved in this event? right hip.B.What was the allegation against the head? metallosis provided by the head scratching on the metal cup (due to pe liner wear).
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: cup revision surgery after 10 years from implant surgeon gianfranco orengo wants to know why there was so much wear of the poly liner after only 10 years.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device found that the pinnacle sector ii cup 50mm has signs of organic material and what appears to be bone ingrowth adhered to the outer fixation surface.Inside the articulating surface of the cup, only signs of extraction attempts were found.Nothing indicative of a device nonconformance were observed.A manufacturing record evaluation was performed for the finished device product description: pinnacle sector ii cup 50mm product code: 121722050 lot number: 7968091 and no non-conformances or manufacturing irregularities were identified.The overall complaint was not confirmed as the observed condition of the pinnacle sector ii cup 50mm would have not contributed to the reported adverse event.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: a manufacturing record evaluation was performed for the finished device product description: pinnacle sector ii cup 50mm product code: 121722050 lot number: 7968091 and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: pinnacle sector ii cup 50mm product code: 121722050 lot number: 7968091 and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: h3.

• Brand Name: PINNACLE SECTOR II CUP 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): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19782025
• Report Number: 1818910-2024-15464
• Device Sequence Number: 8278441
• Product Code: LPH
• UDI-Device Identifier: 10603295009818
• UDI-Public: (01)10603295009818(17)240731(10)7968091
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P070026
• 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
• Report Date (Section B): 07/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Catalogue Number: 121722050
• Device Lot Number: 7968091
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 08/13/2024; 10/04/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 08/02/2024; 08/14/2024; 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2014
• 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 +1.; PINN MAR +4 10D 32IDX50OD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female