MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, 36/+7, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEADS, BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision due to implant fracture.It was reported that the ceramic head fractured and broke in the patient.Patient outcome - revision surgery.
Additional Manufacturer Narrative
The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d4, d6, d9, g3, g6, h1, h2, h6, h10 review of the device history records identified no deviations or anomalies during manufacturing.Further, the density and the grain size of the femoral head were analysed and found to comply with the delivered specification for biolox delta components.The microstructure as obtained from the quality documents meets the requirements specified at the time of production.There is no indication of any pre-existing material defect.This device was returned to ceramtec for examination: visual examination of the returned device identified that the head is fractured into three large and nine small fragments.The ceramic femoral head cannot be completely reconstructed from the delivered fragments.The articulation and fracture surfaces show secondary metal transfer.This secondary metal transfer was probably produced as a result of contact with metal parts and/or surgical instruments.On two fragments, the primary metal transfer cannot be found on the cone of the femoral head.This indicates that the interface was disturbed during the assembly of the femoral head and stem, potentially caused by contamination such as blood or tissue.Such disturbance can lead to a decrease of the burst strength of the femoral head.Due to secondary damage and missing fragments the fracture origin cannot be identified on the fragments of the femoral head.Device is used for treatment.Two radiographs were submitted showing that the head is not centered around the visible taper.In addition, radiopaque fragments can be seen around the head.Based on the radiographs provided and the returned device, the reported event can be confirmed.A disturbance at the interface between stem and femoral head leading to an increase of mechanical stress, is a potential reason for the fracture of the ceramic femoral head.However, since the cause may be multifactorial, a definitive 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, 36/+7, TAPER 12/14
• Common Device Name: BIOLOX DELTA CERAMIC FEMORAL HEADS, BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14074942
• Report Number: 0009613350-2022-00222
• Device Sequence Number: 6057053
• Product Code: LZO
• UDI-Device Identifier: 00889024430389
• UDI-Public: (01)00889024430389(17)210331(10)2602728
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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 Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-04
• Device Lot Number: 2602728
• Was Device Available for Evaluation?: Yes
• 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: 03/16/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2011
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 188 KG