MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX OPTION TAPER SLEEVE 0MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unequal Limb Length (4534); Insufficient Information (4580)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 ¿ cer bioloxd option hd 28mm, item# 650-1055, lot# 3094909.Vivacit-e dm bearing 28x44mm, item# 110031012, lot# 64912289.Oss finn mod prox fmrl rt 7cm, item# 150457, lot# 667980.Oss 7cm diahpyseal segment, item# 150466, lot# 183630.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2024 - 00082.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 that the patient underwent a revision procedure of the right hip to create a shorter construct due to patient's anatomy.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
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 that could be related to the reported event.With the available information, a definitive root cause could not be determined.It is likely the root cause is not related to the items reported on this complaint as we have received the following information: revision procedure to create a shorter construct for the patient.There was nothing wrong with the implant.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h11.The following sections were corrected: h6.Based on the available information, the reported event cannot be confirmed.With the available information, a definitive root cause could not be determined.It is likely the root cause is not related to the items reported on this complaint as we have received the following information that the patient was skeletally immature and did not grow as fast as expected which led to needing to shorten the construct to match the other leg.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
It was reported that the patient underwent a revision procedure of the right hip to create a shorter construct due to patient's anatomy.The patient was skeletally immature and did not grow as fast as expected which led to needing to shorten the construct to match the other leg.Attempts have been made and no further information has been provided.

• Brand Name: BIOLOX OPTION TAPER SLEEVE 0MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 18873113
• Report Number: 3002806535-2024-00083
• Device Sequence Number: 7935602
• Product Code: LZO
• UDI-Device Identifier: 00887868271489
• UDI-Public: (01)00887868271489(17)320920(10)3128066
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 09/18/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1066
• Device Lot Number: 3128066
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 05/03/2024; 08/26/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 05/09/2024; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose