MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® OPTION, HEAD, L, ø 40/+3.5, TAPER 12/14; HIP PROSTHESIS

Catalog Number	00-8777-040-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: femoral stem 12/14 neck taper, #item 00811400218, #lot 65514628.Allen medullary cement, #item 00801102016, #lot 65251526.Therapy date: on (b)(6) 2025.G2: foreign report source: australia.Attempts have been made to gather all product identification information and no further information has been provided.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 that a patient underwent a hip revision approximately 2 years post-implantation due to instability for unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Corrected/updated: b4, b5, d1, d2, d4, g1, g3, g6, h1, h2, h4.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 additional event information.
Additional Manufacturer Narrative
Follow up report.(b)(4).Updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6.Corrected: d4.The product involved in the reported event was not returned for investigation; however, a picture of the explanted femoral head in the operating theatre was provided and reviewed.The picture shows the seating side of the femoral head.The femoral head is covered in organic residue (blood).Metallic smearings can be seen on the seating surface of the femoral head as well as in the taper.Insufficient information provided.Unable to perform a compatibility check.The liner and g7 cup information is unknown.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Implant labels and surgical notes were provided for the implantation dated and reviewed by a healthcare professional with the following findings: the patient was classified as asa iii and underwent general anesthesia combined with spinal anesthesia.The specimen was sent to pathology.The femur was found to be grossly loose and was explanted with minimal bone loss, and competitor products were also explanted.No further medical records were provided.A definitive root cause cannot be determined.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 additional event information.

• Brand Name: BIOLOX® OPTION, HEAD, L, ø 40/+3.5, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• 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: 22375295
• Report Number: 0009613350-2025-00478
• Device Sequence Number: 8091615
• Product Code: LZO
• UDI-Device Identifier: 00889024430570
• UDI-Public: (01)00889024430570(17)240131(10)2745088
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200112
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2025

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 Expiration Date: 01/31/2024
• Device Catalogue Number: 00-8777-040-03
• Device Lot Number: 2745088
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 10/03/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/28/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2014
• 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; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female