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

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Title: cementless unicompartmental knee arthroplasty results in higher pain levels compared to the cemented technique: a prospective register study.Authors: tone gifstad· jørgen jebens nordskar · tarjei egeberg · tina strømdal wik · siri bjørgen winther.Published 25 may 2021.On 06 sep 2021, a journal article was retrieved by our clinical team that reported a study from norway which compared patient-reported outcome measures (proms) from the cemented versus cementless techniques two- and twelve-months post-operation.The study retrospectively analysed 187 cemented and 261 cementless ukas from 2015 to 2019.The oxford unicompartmental knee system was used for all patients.The main finding from the present study was significantly lower scores for activity-related pain infavour of the cemented group at both two- and twelve-month follow-up.Also, pain at rest at twelvemonth follow-up and koosps at two-month follow-up were significantly lower in the cemented group.There was a significant reduction in duration of surgery for the cementless group, but a relatively high number of prosthetic joint infections were found in that same group.The study reports revision due instability.

Manufacturer Narrative

(b)(4).This is a combined initial/final report and is being submitted to relay information.Report source, foreign - event occurred in (b)(6).The product will not be returned to zimmer biomet for an investigation as the product location is unknown.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: 3002806535-2022-00169, 3002806535-2022-00171.Complaint summary: product has not been returned for evaluation.The item and lot number have not been provided.X-rays or medical notes have not been provided.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.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.

• Brand Name: UNKNOWN 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: 13869514
• MDR Text Key: 291837002
• Report Number: 3002806535-2022-00170
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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: 09/06/2021
• 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