MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI FEMORAL SM; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); No Information (3190)

Event Date 05/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that a patient had material fracture of the femoral component of a sled prosthesis knee left (oxford knee).

Manufacturer Narrative

(b)(4).The follow up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from customer.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.

Event Description

It has been reported that a patient had material fracture of the femoral component of a sled prosthesis knee left (oxford knee).

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.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.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3 - report source, foreign - event occurred in germany.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 any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database has found no similar complaints reported with the item 154600.Without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.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 there was an implant failure of a sledge prosthesis (femoral component) due to loosening caused by wear with lateral instability of the lateral tendons and mobility failure on the left.Subsequently, a revision was performed with no delay.Revision: replacement of a unicondylar sledge prosthesis with a femoral and tibial shaft-anchored prosthesis, hybrid (partially cemented).

• Brand Name: OXFORD UNI FEMORAL SM
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7621121
• MDR Text Key: 111736050
• Report Number: 3002806535-2018-00899
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: N/A
• Device Catalogue Number: 154600
• Device Lot Number: 1132973
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2020
• 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
• Patient Age: 76 YR
• Patient Weight: 85