MAUDE Adverse Event Report: DePuy Orthopaedics Inc US PINNACLE GRIPTION; Pinnacle Hip System : Hip Metal Acetabular Cups

Catalog Number	121732050
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent hip arthroplasty surgery in 2022.Components implanted were corail femoral stem, 32mm +1 articuleze metal head, 32/50 +4 10 degree pinnacle marathon acetabular liner, and 50mm pinnacle sector gription shell.Surgery was completed successfully at the time.In (b)(6) 2026, patient notified the surgeon that they ¿had felt a pop in their hip region and hip felt odd¿.X-rays showed that revision surgery was necessary.During the hip revision surgery, the surgeon discovered that the acetabular liner was partially dissociated.The liner was partially dissociated in the posterior aspect.The surgeon then removed the partially dissociated liner and the previous femoral head.The liner was replaced with an altrex polyethylene one of identical dimensions.Surgeon also replaced the femoral head with a biolox delta ceramic head of identical dimensions.The hip was then reduced and surgery finished successfully according to plan.No additional information is available.
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.Additional narrative: h3, h6: no device associated with this report was received for examination.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot = > there is 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE GRIPTION
• Common Device Name: Pinnacle Hip System : Hip Metal Acetabular Cups
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer (Section G): Cork Mfg & Material Warehouse; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50059959
• Report Number: 1818910-2026-12863
• Device Sequence Number: 10665792
• Product Code: JDI
• UDI-Device Identifier: 10603295010296
• UDI-Public: (01)10603295010296(17)320731(10)3889313
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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 Catalogue Number: 121732050
• Device Lot Number: 3889313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown