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

Catalog Number	136536310
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Liner breakage post-op.The patient underwent total hip arthroplasty on (b)(6) 2026, due to femoral head necrosis.Delta ceramic head and ceramic liner were implanted.The hospital reported that the surgical process and postoperative rehabilitation treatment were smooth.Three months after surgery (b)(6) 2026), the patient sought medical attention due to self perceived discomfort and reported no history of fall, impact, or strenuous exercise.X-ray examination revealed that the ceramic liner was broken.The doctor performed a second surgery on the patient and removed the broken liner.Since the ceramic head was worn by the fragment, the ceramic head was removed together.The patient is currently in a stable condition and no subsequent adverse event reports have been received.
Additional Manufacturer Narrative
Product complaint # (b)(4)\ investigation summary = > according to the information provided: \"liner breakage post-op.The patient underwent surgery in early january and had no history of wrestling after the surgery.One week ago, the patient felt unwell and was recently admitted for examination.X-ray examination revealed ceramic liner broke.The patient is currently waiting for a second surgery\" and \"after investigation, the patient underwent total hip arthroplasty in the hospital due to \"femoral head necrosis\" in (b)(6) 2026.121881752 and 136536310 were implanted during the surgery.The hospital reported that the surgical process and postoperative rehabilitation treatment were smooth.Three months after surgery (b)(6) 2026), the patient sought medical attention due to self perceived discomfort and reported no history of fall, impact, or strenuous exercise, and the liner was found to be broken by x-ray.The doctor then performed a second surgery on the patient and removed the broken liner.Since the ceramic head was worn by the fragment, the ceramic head was removed together.The patient is currently in a stable condition and no subsequent adverse event reports have been received\".\ \ ¿the product was not returned to depuy synthes, however photos were provided for review.See attachment (¿¿¿¿¿x¿.Jpg).\ \ the x-ray evidence was reviewed, however with information provided, there is no certainty nor evidence to verify the wear reported in the ceramic head.\ \ a manufacturing record evaluation was performed for the finished device 4827579 lot number, and one non-conformance was identified, however not related to the reported failure mode of the complaint.\ \ as the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.\ \ the overall complaint was not confirmed as the observed condition of the delta cer head 12/14 36mm +1.5 would have not contributed to the complained device issue.¿\ \ based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.\ \ device history lot = > quantity manufactured:- 20\ date of manufacturing:- 15- jun-2025\ any anomalies or deviations identified in dhr: one non-conformance was identified but not related to failure mode of the complaint.\ expiry date:- 31-may-2030\ ifu reference:- 090200701\ \ device history review = > a manufacturing record evaluation was performed for the finished device 4827579 lot number, and one non-conformance was identified, however not related to the reported failure mode of the complaint.

• 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 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: 25365419
• Report Number: 1818910-2026-09590
• Device Sequence Number: 9892102
• Product Code: LZO
• UDI-Device Identifier: 10603295033615
• UDI-Public: (01)10603295033615(17)300531(10)4827579
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 136536310
• Device Lot Number: 4827579
• 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: 05/11/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown