MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 4 PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 03/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: unknown oxford femoral component, catalog #: not reported, lot #: not reported; medical product: unknown oxford tibial component, catalog #: not reported, lot #: not reported.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00413, 3002806535-2019-00414.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial left knee replacement procedure.Subsequently, the patient was revised due to loosening.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Medical product: oxf twin peg cmntls fmrl lg catalog #: 161475 lot #: r3050588a.Medical product: oxford cementless tibia f lm catalog #: us166580 lot #: r3058145a.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.

Event Description

It was reported that a patient underwent an initial left knee replacement procedure.Subsequently, the patient was revised due to loosening.

Event Description

The patient stated in a 6-week checkup that the uni knee looked good after implanted.Its reported that the patient went horse riding not long after and as he got off the horse his knee buckled.Furthermore, the patient struggled to walk and the knee gave out and snapped.The pain occurs mostly at night.The doctor claims its a mechanical error.Subsequently, the patient stated his swelling has gone down since he was revised and implanted with full knee.This report is based on allegations and the allegations there in are unverified.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.It is not possible to determine the cause of revision in this instance without examining the revised components and without additional information such as surgical notes, post-primary x-rays, better quality x-rays (including mediolateral x-rays), as well as patient information (height, weight, activity level) being provided.Device history record (dhr) was reviewed and no discrepancies were found.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.

• Brand Name: OXF ANAT BRG LT LG SIZE 4 PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8567947
• MDR Text Key: 143665738
• Report Number: 3002806535-2019-00415
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2023
• Device Model Number: N/A
• Device Catalogue Number: 159555
• Device Lot Number: 473010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention