MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BIOLOX DELTA; HIP CERAMIC FEMORAL HEAD

Catalog Number	136532730
Medical Device Problem Codes	Naturally Worn (2988); Noise, Audible (3273)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2026
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.H11 additional manufacturer narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that the patient presented with noisy hip, after x-rays it was noted that the polyethylene liner had moved and the ceramic head was wearing on the metal cup.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: patient presented with noisy hip, after x-rays it was noted that the polyethylene liner had moved and the ceramic head was wearing on the metal cup.The product was not returned to depuy synthes; however, photos were provided for review.Review of the photos and x-ray revealed the acetabular cup in contact with the ceramic head which could have been due to a disassociation between the acetabular cup and the liner.Additionally, ceramic head shows metal transfer at the convex surface, most likely caused by the contact between the head and acetabular cup after the disassociation event occurred.It is not unreasonable that noise would be present due to the ceramic head articulating against the metal cup.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the dlt ts cer hd 12/14 32mm +9 would have 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: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.Added: d1, d10 (concomitant).

• Brand Name: BIOLOX DELTA
• Common Device Name: HIP CERAMIC FEMORAL HEAD
• 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: 24391188
• Report Number: 1818910-2026-03298
• Device Sequence Number: 10504220
• Product Code: LZO
• UDI-Device Identifier: 10603295033486
• UDI-Public: (01)10603295033486
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 136532730
• Device Lot Number: M0320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/28/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALTRX +4 10D 32IDX48OD.; UNKNOWN HIP ACETABULAR CUP.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female