MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX OPTION TAPER ADAPTER TYPE 1 SLEVE +6; PROSTHESIS, HIP

Catalog Number	650-1068
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: item#:650-1057 ;lot#:2958797 ;item name: cer bioloxd option hd 36mm ; d10 - therapy date: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00387.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient is being considered for revision surgery on an unknown date, due to unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.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.Device is used for treatment.Medical records were not provided.With the available information, 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: a1-a3, b1, b2, b4, b5, d1, g3, g6, h1, h2, h3, h6, h11.The following sections were corrected: h4.D10: 110010247, g7 osseoti 4 hole shell,58mm g, lot # 6630992.30103607, 36mm i.D.Size g neutral liner, lot # 64358597.51-103140, tprlc 133 t1 pps so 14x148mm, lot # 6626648.Further investigated following receipt of x-rays.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: acetabuli protrusio of the acetabular component with subsidence of the femoral component and dislocation of the femoral head.Fracture superomedial and anterior acetabulum.With the available information, a definitive root cause could not be determined.It is unknown which of the events (dislocation, stem subsidence, or shell loosening) occurred first.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
It was reported that a patient underwent a right hip arthroplasty on an unknown date.The patient is being considered for revision surgery on an unknown date, due to unknown reasons.X-rays received and reviewed, noting loosening of the acetabular component, subsidence of the femoral component, dislocation of the femoral head, and bone fracture of the acetabulum.Attempts have been made and no further information has been provided.

• Brand Name: BIOLOX OPTION TAPER ADAPTER TYPE 1 SLEVE +6
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18146715
• Report Number: 3002806535-2023-00388
• Device Sequence Number: 7540431
• Product Code: LZO
• UDI-Device Identifier: 00887868271502
• UDI-Public: (01)00887868271502(17)290104(10)2965056
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K082996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2024

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 Catalogue Number: 650-1068
• Device Lot Number: 2965056
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 11/28/2023; 05/02/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/21/2023; 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2019
• 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 H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male