MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121722052
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
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.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 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).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 not returned to depuy synthes for evaluation.Although the cup was not returned for evaluation however due to the condition of the returned liner and the ceramic head it is reasonable to conclude that a disassociation event occurred between the liner and the cup.Furthermore, the wear allegation cannot be confirmed with the provided information with the information provided is not possible to determine a potential cause at this moment.The mode of failure of the pinnacle sector ii cup 52mm 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.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.A manufacturing record evaluation was performed for the finished device product description: pinnacle sector ii cup 52mm product code: 121722052 lot number: 3752440 and no non-conformances or manufacturing irregularities were identified.The overall complaint was confirmed based on the visual examination of the liner and the ceramic head condition.The pinnacle sector ii cup 52mm would have contribute 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 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: pinnacle sector ii cup 52mm product code: 121722052 lot number: 3752440 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 52mm product code: 121722052 lot number: 3752440 and no non-conformances or manufacturing irregularities were identified.
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, d10 (concomitant), h6 (medical device problem code).Corrected: h6 (health effect - impact 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.

• Brand Name: PINNACLE SECTOR II CUP 52MM
• 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: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23546997
• Report Number: 1818910-2025-19785
• Device Sequence Number: 9283492
• Product Code: LPH
• UDI-Device Identifier: 10603295009825
• UDI-Public: (01)10603295009825(17)320331(10)3752440
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: P070026
• 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

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: 121722052
• Device Lot Number: 3752440
• Was Device Available for Evaluation?: No
• 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
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 11/26/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2022
• 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; PINN MAR NEUT 32IDX52OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown