MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, ø 36/+7, TAPER 12/14; PROSTHESIS, HIP

Catalog Number	00877503604
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): d10: item # unknown, unknown cup, lot # unknown.Item # unknown, unknown liner, lot # unknown.G2: report source netherlands.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent hip revision approximately 8 months post implantation due to the patient heard a cracking sound and upon sitting heard a weird sound and immediately felt something was wrong.It was later found that the head component had fractured, and the patient was revised approximately 8 months post-implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that the patient underwent a hip revision approximately 8 months post-implantation due to a fractured ceramic femoral head.The patient previously underwent an initial hip arthroplasty for a femoral neck fracture on an unknown date.Approximately one week prior to the event, the patient heard a cracking sound.Subsequently, while sitting, the patient heard a unusual sound and immediately felt something was wrong.Evaluation revealed that the femoral head component had fractured.The hip construct included a stem and an acetabular cup.A review of manufacturing records and the certificate of conformance reportedly identified no abnormalities or deviations.No specific environmental factors were reported other than the patient¿s seated position at the time the unusual sound was noted.The patient underwent revision surgery.No further details regarding intra-operative findings or the patient¿s post-revision condition were provided.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b7, d9, g3, g6, h2, h3, h6, h11.D10: item # unknown, unknown cup, lot # unknown.Item # 30103606, g7 vit e neutral lnr 36mm f, lot # 66664479.The analysis of the fractured femoral head showed that the material complied with all manufacturing and quality specifications for biolox® delta ceramic components.No evidence of pre-existing material defects or abnormalities was found.Metal transfer patterns observed on the fracture fragments indicate contact between the femoral head and metal components or surgical instruments.While primary metal transfer was expected on the conical bore surface, its evaluation was limited due to overlaying secondary metal transfer.The absence of primary metal transfer in the middle of the conical bore suggests a disturbance during assembly of the femoral head and metal stem.Localized, intensive metal transfer in certain regions points to increased loading near the distal end of the cone.Although the primary fracture surfaces and region could be identified, the exact fracture origin could not be conclusively determined because of secondary damage and missing fragments.Material analysis of the transferred metal revealed cobalt, chromium, nickel, and molybdenum, elements consistent with the metallic stem.This supports the conclusion that the metal transfer resulted from contact between the femoral head and the stem taper.Overall, the findings indicate that insufficient or incorrect seating of the femoral head on the metal stem taper, likely due to malpositioning, led to localized mechanical stress.This stress is considered the most probable cause of the ceramic femoral head fracture.The concomitant pe liner was additionally returned to the product surveillance team for examination.The device shows damage in the form of scuffing, especially on the articulating surface, likely occurring after the fracture of the femoral head.There are some ceramic fragments on and embedded on the surface as well as some black/metallic smearing.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.One undated x-ray of the left hip was provided confirming femoral head fracture.The investigation confirms a fracture of the femoral head.Component properties and microstructure meet production specifications, with no evidence of pre-existing material defects.However, overall, the findings indicate that insufficient or incorrect seating of the femoral head on the metal stem taper, likely due to malpositioning, led to localized mechanical stress.This stress is considered the most probable cause of the ceramic femoral head fracture.If and to what extent other factors may have led or contributed to the reported event remains unknown.Therefore, a definitive root cause could not be identified.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 FEMORAL HEAD, XL, ø 36/+7, 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21950880
• Report Number: 0009613350-2025-00355
• Device Sequence Number: 8800479
• Product Code: LZO
• UDI-Device Identifier: 00889024430389
• UDI-Public: (01)00889024430389(17)340307(10)3195259
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 10/27/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00877503604
• Device Lot Number: 3195259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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: Female
• Patient Weight: 80 KG