MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14; PROSTHESIS, HIP

Catalog Number	00877503602
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544); Unequal Limb Length (4534); Joint Impingement (4834)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item#: 00620205222, shell porous with cluster holes 52 mm, lot#: 62910365.Item#: 00630505036, liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells, lot#: 66007274.Item#: 00771101140, femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 11 extended offset reduced neck length, lot#: 65626149.Item#: 00625006525, bone screw self-tapping 6.5 mm dia.25 mm length, lot#: 66240769.Item#: 00625006525, bone screw self-tapping 6.5 mm dia.25 mm length, lot#: 66268595.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
It was reported the patient had an initial right total hip arthroplasty and, subsequently reported pain, popping and grinding noise when walking, and difficulty with movement.Ct as well as exam noted leg length discrepancy.Approximately 1.5 years post-implantation, the patient had a right total hip revision.During the revision, thick capsule with posterior impingement of the trochanter on the pelvis was noted as well as a slightly retroverted acetabular cup.Trunnion was found to be clean without significant damage.The cup, liner, and head were revised without complications.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4): this follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.Corrected: h6 (health effect - clinical codes).No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed on (b)(6) 2023.The patient began experiencing pain, popping, and grinding with difficulty ambulating and a leg length discrepancy.The revision took place approximately 1 years and 3 months post implantation, with impingement noted as well and the cup was found slightly retroverted.Based on the information available, it remains unknown if, or to what extent, the leg length discrepancy, the slightly retroverted cup and the impingement are connected, and whether they contributed to the reported symptoms leading to the revision surgery.Therefore, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21740386
• Report Number: 0009613350-2025-00211
• Device Sequence Number: 19889354
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)330531(10)3144586
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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: Lay User/Patient
• Device Catalogue Number: 00877503602
• Device Lot Number: 3144586
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 92 KG