MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L 32/+3.5, TAPER 12/14; BIOLOX HIP PROTHESIS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Subluxation (4525)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately three years post-implantation, the patient underwent a hip revision due to dislocation and subluxation.The liner and modular head were revised.Due diligence has been completed for this complaint; to date all available additional information has been received.
Additional Manufacturer Narrative
(b)(4).D10: 32mm i.D.Size hh neutral liner use with 50mm o.D.Size hh shell item #00875100932 lot #64725558.50mm o.D.Size hh porous uncemented with cluster holes shell use with hh liners for export only item #65875305001 lot #64819335.Femoral stem cementless collared standard offset 12/14 taper size 2 item #574201020 lot #3048552.G2: foreign ¿ united kingdom.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
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 or pictures provided; visual and dimensional evaluations 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.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Based on the available information, the reported event cannot be confirmed and a definitive root cause cannot be established.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
Due diligence has been completed for this complaint; to date all available additional information has been received.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L 32/+3.5, TAPER 12/14
• Common Device Name: BIOLOX HIP PROTHESIS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• 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: 20224705
• Report Number: 0009613350-2024-00452
• Device Sequence Number: 17020389
• Product Code: LZO
• UDI-Device Identifier: 00889024430334
• UDI-Public: (01)00889024430334(17)300228(10)3020602
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: 00877503203
• Device Lot Number: 3020602
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2020
• 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 Age: 83 YR
• Patient Sex: Female