MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ASPHERE; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number	136552100
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
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) 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.E3 initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary = > no device associated with this report was received for examination.The adverse symptoms alleged and product code reported is associated with the depuy metal on metal articulation.A complaint database search and/or device manufacturing (dhr) reviews will not be performed.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 = > a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.Added: d10 (concomitant).

• Brand Name: ASPHERE
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• 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: 25006700
• Report Number: 1818910-2026-07672
• Device Sequence Number: 15647765
• Product Code: KWA
• UDI-Device Identifier: 10603295033943
• UDI-Public: (01)10603295033943(17)150312(10)3102332
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082585
• 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: 03/12/2015
• Device Catalogue Number: 136552100
• Device Lot Number: 3102332
• 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: 05/01/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2010
• 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: PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX40MM; PINNACLE MTL INS NEUT36IDX52OD; PINNACLE SECTOR II CUP 52MM; SUMMIT DUOFIX TAP SZ3 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female