MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 28/+3.5, TAPER 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item # ep-200146, act artic e1 hip brg 28x40mm, lot # 66035664; item # 110024462, g7 dual mobility liner 40mm d, lot # 66006305; item # 31-323230, 3.2mmx30mm rnglc+ acet drl bit, lot #66103730; item # 110010263, g7 osseoti multihole 50mm d, lot # 7499300; item # 010000996, g7 screw 6.5mm x 15mm, lot #7160391; item # 8011-20-20, allen medullary cement plug, lot # 66032745; item # 010000998, g7 screw 6.5mm x 25mm, lot # 7543654; item # 110024462, g7 dual mobility liner 40mm d, lot # 66006305.G2: report source 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
It was reported patient underwent hip revision approximately 1 year post implantation due to a disassociated dual mobility.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.No product was returned for evaluation.Several intra-op pictures were received.On one picture the biolox ceramic femoral head can be seen implanted on the stem.A review of all relevant 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 not provided.However, two documents with stickers were submitted.One document, stickers 2, shows a part of a surgery report with the label attached to it.The date of surgery or other relevant data cannot be identified.The reported event mentions a disassociated dual mobility.The following information was received: were there any contributing conditions related to the event: yes, fall.Therefore, it can be highly assumed that the disassociated dual mobility occurred due to the fall.However, as no further information is available, a definitive root cause could not 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 further event information available at the time of this report.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 28/+3.5, 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20482956
• Report Number: 0009613350-2024-00492
• Device Sequence Number: 3615457
• Product Code: LZO
• UDI-Device Identifier: 00889024430303
• UDI-Public: (01)00889024430303(17)330303(10)3143977
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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 Model Number: N/A
• Device Catalogue Number: 00877502803
• Device Lot Number: 3143977
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 52 KG