MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121722056
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a revision of a c-stem pinnacle.The reason for revision was because the stem was loose, and the hip was unstable.No allegation was made by the surgeon in relation to the loose stem.The cement/stem interface was loose.Cement bone/bone interface was sound.The surgeon noted that it was a very difficult primary.It was done by a different surgeon and they struggled to get a sz 1ho c-stem in.The x-ray showed that due to the anterior-lateral approach, the stem was put in varus.The hip was unstable because at the primary surgery, the cup was placed at the wrong version.The cup was explanted.It was extremely well fixed.The liner was explanted with the shell, but the lot number is unreadable as the liner was damaged when explanted.Reclaim bimentum was implanted.Affected side: right side.
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 narrative: d6a: implantation day was unknown date in 2014.H3, h6 investigation summary: the product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed nothing indicative of a device nonconformance.At the evidence provided it can bee seen only the pinnacle sector ii cup 56mm assembled wit the pinn mar neut 32idx56od.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.The overall complaint was not confirmed as the observed condition of the pinnacle sector ii cup 56mm would have not contributed to the complained device 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.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.

• Brand Name: PINNACLE SECTOR II CUP 56MM
• 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: 21687929
• Report Number: 1818910-2025-04531
• Device Sequence Number: 12974180
• Product Code: LPH
• UDI-Device Identifier: 10603295009849
• UDI-Public: (01)10603295009849(17)230630(10)5815087
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

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: 06/30/2023
• Device Catalogue Number: 121722056
• Device Lot Number: 5815087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2013
• 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: UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown