MAUDE Adverse Event Report: DePuy Orthopaedics Inc US ARTICULEZE M HEAD 36MM -2; Articuleze Head (12/14 Taper) : Hip Metal Femoral Heads

Catalog Number	136550000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Synovitis (2094); Discomfort (2330); Metal Related Pathology (4530)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6)2009, patient had a surgery of total hip arthroplasty indicated for osteoarthritis of the left hip.(b)(6)2024: patient is experiencing left knee pain for 3 weeks.Pain is expected to be secondary to left knee osteoarthritis with exacerbation.No implants are currently present in the knee.Patient underwent a left knee injection and arthrocentesis.On (b)(6)2025, patient was revised due to developing pain in the left hip.Patient has a history of metal-on-metal prosthesis on both sides.Patient had metal ions assessed which unfortunately were significantly elevated.Through the operation, it was identified there was some mildly hemorrhagic bursitis which was carefully debrided.There were some inflamed synovial fronds both anteriorly and posteriorly and these were debrided.There was significant bony overgrowth anteriorly and this was debrided patient reports experiencing a sensation of grinding in her hip when bending over to tie her shoe but does not experience any associated pain.Patient recalls an isolated incident of pain on the contralateral side but has not experienced any subsequent discomfort.Patient reports satisfactory progress with her left hip, experiencing only mild discomfort during the initial steps of movement.The surgical incision appears to be healing well, with no signs of redness or drainage.Patient mentions that she has been ambulating without the aid of a cane for the past week and a few days.Doi: (b)(6) 2009.Dor: (b)(6)2025.Affected part: left hip.
Additional Manufacturer Narrative
Product complaint #pc-002239391 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.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 a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

• Brand Name: ARTICULEZE M HEAD 36MM -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 -098
• Manufacturer (Section G): JTE Warsaw Mfg Site; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50691091
• Report Number: 1818910-2026-15342
• Device Sequence Number: 18540644
• Product Code: JDI
• UDI-Device Identifier: 10603295033899
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2019
• Device Catalogue Number: 136550000
• Device Lot Number: 2817866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2009
• 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 Age: 40 YR
• Patient Sex: Female