MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD FEMORAL COMPONENT; KNEE PROTHESIS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is a combined initial / final report.Report source, foreign - event occurred in (b)(6).The product will not be returned to zimmer biomet for investigation as the product location is unknown.Product has not been returned for evaluation.Medical product: unknown oxford tibial component, catalog #: unknown, lot #: unknown.Medical product: unknown oxford bearing component, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00109, 3002806535-2022-00108.The item and lot number have not been provided.X-rays or medical notes have not been provided.The investigation has been limited to the information provided.A historical search could not be performed as the item and lot number have not been provided.This device is used for treatment.Not enough information has been provided to determine if all implants are compatible.A dhr review or a review of recalls could not be performed as the item and lot number have not been provided.Unable to perform previous field action search as item and lot number have not been provided.The likely condition of the device when it left zimmer biomet could not be determined as the item and lot number has not been provided.The root cause of the reported event can not be determined with the information provided.No corrective action required at this time as the root cause of the reported event has not been determined.

Event Description

Title: functional results of total-knee arthroplasty versus medial unicompartmental arthroplasty: two year results of a randomised, assessorblinded multicentre trial.Authors: jani knifsund , tuukka niinimaki, heikki nurmi, alar toom, hannes keemu, inari laaksonen, matti seppänen, antti liukas, konsta pamilo, t vahlberg, ville äärimaa, kt mäkelä.Published on 17 may 2021.On 14 sep 2021, a journal article was retrieved by our clinical team that reported a study from finland which looked at the effect of the clinical effectiveness of medial unicompartmental knee arthroplasty versus total knee arthroplasty in patients with isolated medial osteoarthritis of the knee.This study analysed the patients who were enrolled between december 2015 and may 2018 from the outpatient clinics of three public highvolume arthroplasty hospitals (finland).143 patients with symptomatic-isolated medial osteoarthritis of the knee needing an arthroplasty procedure.All the patients were suitable for both unicompartmental and total knee arthroplasties.The recovery after unicompartmental knee arthroplasty was faster compared with total knee arthroplasty, but unicompartmental arthroplasty did not provide a better patient-reported outcome at 2 years.The study reports revision due to postoperative haematoma in two patients.

• Brand Name: UNK OXFORD FEMORAL COMPONENT
• Type of Device: KNEE PROTHESIS
• 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: 13799074
• MDR Text Key: 289686924
• Report Number: 3002806535-2022-00110
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN OXF FEMORAL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention