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

Catalog Number	136536320
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Nerve Damage (1979); Physical Asymmetry (4573)
Date of Event	09/10/2026
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported on (b)(6) 2026, a rtc with ceramic head was performed.During the evaluation carried out post-operatively it was evident that the patient presented with a fall.This was apparently associated with a sciatic nerve injury, as well as a difference in the length of the lower extremities.The operated limb longer than the contralateral.Dr states that during the procedure he used a head 36 +1.5 mm, corresponding to the shortest option available.However, the resident of orthopedics informed him that, when reviewing the surgical expenses, the reference registered and billed corresponds to a 36 +5 mm head.According to the information provided by dr, an error could have occurred in the delivery of the implant during the procedure.The doctor says that he requested the surgical support, identified as óscar, the shortest head available.He also comments that the reduction was technically difficult during the surgery, although at that time he did not consider it to be related to the size of the implanted head.Revision surgery has been planned with the aim of making the change to the head of shorter length.

• 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: 50945420
• Report Number: 1818910-2026-16868
• Device Sequence Number: 13374781
• Product Code: LZO
• UDI-Device Identifier: 10603295033622
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K031803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 136536320
• Device Lot Number: 5209362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2026
• 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: 48 YR
• Patient Sex: Male