MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD FEMORAL COMPONENT; PROSTHESIS, KNEE

Catalog Number 161474

Device Problem Unstable (1667)

Patient Problems Pain (1994); Swelling (2091)

Event Date 01/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product- oxford bearing catalog# 159547 lot# 763870, oxford cementless tibial component catalog# us166576 lot# r3511128a.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports:3002806535 - 2017 - 00305, 3002806535 - 2017 - 00306, 3002806535 - 2017 - 00307.

Event Description

It was reported that patient is experiencing pain, instability, and swelling.Anti-inflammatories, icing and elevation were prescribed.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of x-rays provided.Device history record (dhr) was reviewed and no discrepancies were found.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

Event Description

It was reported that patient is experiencing pain, instability, and swelling.Anti-inflammatories, icing and elevation were prescribed.

• Brand Name: OXFORD FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• 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: 6558945
• MDR Text Key: 74872735
• Report Number: 3002806535-2017-00305
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/09/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 161474
• Device Lot Number: R2409862A
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 05/10/2017
• Supplement Dates Manufacturer Received: 12/15/2017; 12/15/2017; 04/16/2019
• Supplement Dates FDA Received: 12/15/2017; 12/15/2017; 05/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 106