MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 36MM +6 NK; HIP ARTHROPLASTY

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Combined initial / final report.Concomitant medical products: medical product: tprlc 133 t1 pps ho 12x144mm, catalog #: 51-104120, lot #: 6786095, medical product: g7 vit e neutral lnr 36mm f, catalog #: 30103606, lot #: 64952318, medical product: g7 pps ltd acet shell 56f, catalog #: 010000665, lot #: 6807678.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.Information received confirmed that no additional information is available.A review of the manufacturing history records confirms no abnormalities or deviations reported.The sterilisation certificates were reviewed and confirmed that product is sterilised within the specification range.A review of the complaint database over the last 3 years has found no similar complaints reported with these items.Risk assessment: risk management report documents the estimated residual risk associated with the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.The reported event states revision due to leg length discrepancy.This incident has a severity score of 3 which is defined in the rmr as: prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The outcome of the reported event (surgical intervention) is in line with the rmf.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
Event or Problem Description
It was reported that the patient underwent left total hip arthroplasty on (b)(6) 2021.Subsequently, the patient underwent a revision procedure on (b)(6) 2021 due to leg length discrepancy.The stem, head and liner were removed and replaced.

• Brand Name: CER BIOLOXD MOD HD 36MM +6 NK
• Common Device Name: HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11491767
• Report Number: 3002806535-2021-00079
• Device Sequence Number: 17139997
• Product Code: LZO
• UDI-Device Identifier: 00887868248504
• UDI-Public: 00887868248504
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K061312
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 12-115123
• Device Lot Number: 2972001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: Hospitalization; Required Intervention