MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC-2; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number	136504000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Osteolysis (2377); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).D6, h4: the information provided regarding the manufacturing date and implantation date are identified to be conflicting.Continued follow-up is being conducted and any additional information received will be reported.E3 initial reporter occupation: lawyer.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.
Event or Problem Description
Litigation and medical records received.Plaintiff had a total hip arthroplasty on april 8, 2008 due to severe degenerative joint disease.Plaintiff underwent a total hip arthroplasty revision on (b)(6) 2023 due to significant osteolytic material noted throughout the proximal femur, grayish type fluid noted throughout soft tissue.Plaintiff underwent workup which showed that there was loosening of the femoral stem.This is a metal on metal articulation and cobalt and chromium blood levels were noted to be elevated and recommended that he proceed with revision of the femoral component and removal of the acetabular liner to convert to a dual mobility type construct.Plans were then made to proceed with revision of acetabulum and femur.Doi: (b)(6) 2008.Dor: (b)(6) 2023.Right hip.

• Brand Name: 12/14 ARTICUL 40MM M SPEC-2
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19527401
• Report Number: 1818910-2024-12806
• Device Sequence Number: 18068415
• Product Code: LPH
• UDI-Device Identifier: 10603295032946
• UDI-Public: (01)10603295032946(10)2233203
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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: 09/18/2011
• Device Catalogue Number: 136504000
• Device Lot Number: 2233203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2020
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORAIL2 NON COL HO SIZE 13; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT40IDX58OD; PINNACLE SECTOR II CUP 58MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male