MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICUL/EZE BALL 28 +1.5 GR; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number	136511000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the primary surgery was performed on (b)(6), 2025.After the surgery, the infection was suspected.The debridement was performed on (b)(6) 2026, (reported on pc (b)(4)) but the infection numbers did not improve.The removal surgery was performed on (b)(6) 2026, during the surgery, the stem was fixed and only the acetabular side was removed.The cement mold was placed and the surgery was completed.
Additional Manufacturer Narrative
Product complaint #pc-(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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.According to the information received, ¿it was reported that on an unknown date, the patient underwent bha with the products.The surgery was completed successfully without any surgical delay.After the surgery, the patient got infection and will be operated to remove all the products on (b)(6) 2026.No further information is available.¿ product description:- articul/eze ball 28 +1.5 gr, product code:- 136511000, lot no:- d25090693, quantity of manufactured:- (b)(4), date of manufacturing:- 09/13/2025, expiry date:- 08/31/2030.A manufacturing record evaluation was performed for the finished device product description: articul/eze ball 28 +1.5 gr product code: 136511000 lot no: d25090693, and no non-conformances / manufacturing irregularities were 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: 09/13/2025, 3) any anomalies or deviations identified in dhr: none.4) expiry date: 08/31/2030.Device history review: a manufacturing record evaluation was performed for the finished device product description: articul/eze ball 28 +1.5 gr product code: 136511000 lot no: d25090693, and no non-conformances / manufacturing irregularities were identified.Added: d6a, d6b, d10 concomitant, h4.

• Brand Name: ARTICUL/EZE BALL 28 +1.5 GR
• 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 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24211666
• Report Number: 1818910-2026-01928
• Device Sequence Number: 9671957
• Product Code: JDI
• UDI-Device Identifier: 10603295033066
• UDI-Public: (01)10603295033066(17)300831(10)D25090693
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K883460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• 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 Catalogue Number: 136511000
• Device Lot Number: D25090693
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2025
• 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: ACTIS COLLARED STD SIZE 6.; J-FX BIPOL SHELL&28MMLINR/51MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 70 KG