MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APEX; PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT

Catalog Number	124603000
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	07/29/2025
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
On (b)(6) 2010, patient underwent a total left hip arthroplasty due to severe degenerative arthritis.On (b)(6) 2025, due to elevated ions and persistent pain, patient underwent revision, left total hip arthroplasty, resection of metallosis including complete synovectomy, irrigation, and debridement.Doi: (b)(6) 2010.Dor: (b)(6) 2025.Affected site: left hip.
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 left hip arthroplasty due to severe degenerative arthritis.On (b)(6) 2025, due to elevated ions and persistent pain, patient underwent revision, left total hip arthroplasty, resection of metallosis including complete synovectomy, irrigation, and debridement.Doi: (b)(6) 2010.Dor: (b)(6) 2025.Affected site: left hip.Product description: apex hole elim positive stop.Product code: 124603000.Lot no: d10020037.Quantity of manufactured: (b)(4).Any anomalies or deviations identified in dhr: no.Date of manufacturing: 10-mar-2010.Expiry date: mar-2020.Ifu reference: (b)(4).A manufacturing record evaluation was performed for the finished device 124603000/ d10020037.It was manufactured on 10-mar-2010.Total (b)(4) parts were manufactured per specification and all raw materials met specification.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: 10-mar-2010.3) any anomalies or deviations identified in dhr: no.4) expiry date: mar-2020.5) ifu reference: (b)(4).Device history review: a manufacturing record evaluation was performed for the finished device 124603000/ d10020037.It was manufactured on 10-mar-2010.Total (b)(4) parts were manufactured per specification and all raw materials met specification.Added: d10 (concomitant), h4.Corrected: d4 (expiration date, primary udi).

• Brand Name: APEX
• Common Device Name: PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT
• 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 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25017724
• Report Number: 1818910-2026-07739
• Device Sequence Number: 9506244
• Product Code: LPH
• UDI-Device Identifier: 10603295019688
• UDI-Public: (01)10603295019688(17)200301(10)D10020037
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K963309
• 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: Consumer,Health Professional
• 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 Expiration Date: 03/01/2020
• Device Catalogue Number: 124603000
• Device Lot Number: D10020037
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2010
• 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: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM -2; PINN CAN BONE SCREW 6.5MMX40MM; PINN SECTOR W/GRIPTION 54MM; PINNACLE MTL INS NEUT36IDX54OD; SUMMIT DUOFIX TAP SZ5 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female