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	Pain (1994)
Date of Event	01/01/2024
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.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
It was reported that a hip revision surgery was planned for (b)(6) 2024 due to the patient's pain.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: planned hip revision surgery due to patient's pain.(b)(6)2024.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device did found that the cup is attached to the liner and unable to disassemble, additionally the pinnacle sector ii cup 50mm has signs of organic material and what appears to be bone ingrowth adhered to the outer fixation surface.No further analysis was able to perform due to the liner stuck in the cup.However, due to the condition altrx neut 32idx50od and the articul/eze ball 32 +1 gr is reasonable to conclude that a disassociation event occurred between the liner and the cup.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device 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.The overall complaint was confirmed as the observed condition of the pinnacle sector ii cup 50mm would have contributed to the reported adverse event.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H11 additional narrative:.

• 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 Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21294952
• Report Number: 1818910-2025-01965
• Device Sequence Number: 21143584
• Product Code: LPH
• UDI-Device Identifier: 10603295009818
• UDI-Public: (01)10603295009818(17)280331(10)8776415
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P070026
• 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

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 Catalogue Number: 121722050
• Device Lot Number: 8776415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown