MAUDE Adverse Event Report: DePuy Orthopaedics Inc US BIOLOX DELTA; Articuleze Head (12/14 Taper) : Hip Ceramic Femoral Heads

Catalog Number	136532320
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a revision hip procedure through a direct lateral approach.The original hip replacement procedure with pinnacle trilock implants was completed 7 years previously.The patient had presented in ae with a two day history of pain, and reported hearing a ¿clunk¿ sound.The revision procedure involved the extraction of a pinnacle sector cup 52mm, a poly 52/32mm, and a 32mm ceramic head.
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 report, a follow-up report will be filed as appropriate.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.

• Brand Name: BIOLOX DELTA
• Common Device Name: Articuleze Head (12/14 Taper) : Hip Ceramic 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: 50083534
• Report Number: 1818910-2026-12984
• Device Sequence Number: 16007382
• Product Code: LZO
• UDI-Device Identifier: 10603295033448
• UDI-Public: (01)10603295033448
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• 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: 136532320
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Female