MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CERAMIC FEM HD 36/-3MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Catalog Number	650-0660
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately two weeks post-implantation, the patient underwent a hip revision due to leg length discrepancy.The leg of the patient was considerably longer, approximately twenty mm, so the surgeon decided to remove the proximal body of the stem and reduce the leg length discrepancy by ten mm.No further information is available.
Additional Manufacturer Narrative
(b)(4).D10: 11-301101, arcos brch sz a std 60mm, lot 569510.G2: foreign - event occurred in australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g2, g3, g6, h2, h3, h6, h11.D:10 unknown g7 cup, lot unknown no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The reported event was confirmed by review of x-rays.Radiographs were reviewed and demonstrates postoperative changes consistent with a left total hip arthroplasty with non cemented components and a single acetabular screw.The acetabular cup inclination appears decreased, measuring approximately 29 degrees.A geographic lucent lesion is present in the left acetabular roof, which may represent either a pre-existing subchondral cyst or osteolysis; this finding is indeterminate without preoperative comparison imaging.The femoral component appears proud relative to the proximal femur/greater trochanter, with mild calcar bone loss.Although calibration was not available for exact measurement, the left lesser trochanter appears at least approximately 1.5 cm distal to the right, suggesting left-sided leg lengthening.The apparent left-sided leg lengthening may be associated with femoral reconstruction factors such as component sizing and/or offset.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of complaint history found no additional related issues for this item and the reported part and lot combination.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOLOX DELTA CERAMIC FEM HD 36/-3MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24648269
• Report Number: 3002806535-2026-00118
• Device Sequence Number: 9786849
• Product Code: LZO
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2026

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: Lay User/Patient
• Device Catalogue Number: 650-0660
• Device Lot Number: 3239463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female