MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE POROCOAT; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121722052
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)
Date of Event	11/03/2025
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 on (b)(6) 2010, patient underwent a total hip arthroplasty due to ehlers-danlos syndrome, dysplastic and degenerative right hip.On (b)(6) 2025, patient underwent a revision, right total hip arthroplasty due to pain, metal on metal wear with elevated metal ion levels prior spinal fusion.Doi: (b)(6) 2010, dor: (b)(6) 2025, affected site: right hip.The related (b)(4) captures revision of the left hip due to elevated ions and persistent pain.
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: no device associated with this report was received for examination.According to the information received, "on (b)(6) 2010, patient underwent a total hip arthroplasty due to ehlers-danlos syndrome, dysplastic and degenerative right hip.On (b)(6) 2025, patient underwent a revision, right total hip arthroplasty due to pain, metal on metal wear with elevated metal ion levels prior spinal fusion.Doi: (b)(6) 2010.Dor: (b)(6) 2025.Affected site: right hip.Product description: pinnacle sector ii cup 52mm.Product code: 121722052.Lot no: ea8la1000.Quantity of manufactured: (b)(4).Date of manufacturing: 08-jan-2010.Expiry date: 06-jan-2020.A manufacturing record evaluation was performed for the finished device product description: pinnacle sector ii cup 52mm, product code: 121722052, lot number: ea8la1000 and no non-conformances / manufacturing irregularities was identified.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: 1) quantity manufactured: (b)(4).2) date of manufacture: 08-jan-2010.3) any anomalies or deviations identified in dhr: none.4) expiry date: 06-jan-2020.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: ea8la1000 and no non-conformances / manufacturing irregularities was identified.Added: d10 concomitant.

• Brand Name: PINNACLE POROCOAT
• 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: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25006640
• Report Number: 1818910-2026-07669
• Device Sequence Number: 8777122
• Product Code: LPH
• UDI-Device Identifier: 10603295009825
• UDI-Public: (01)10603295009825(17)200106(10)EA8LA1000
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare 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 Expiration Date: 01/06/2020
• Device Catalogue Number: 121722052
• Device Lot Number: EA8LA1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2010
• 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: ASPHERE M SPEC 12/14 36 +5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX40MM; PINNACLE MTL INS NEUT36IDX52OD; SUMMIT DUOFIX TAP SZ3 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female