MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB BRG MED SZ5; KNEE PROTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: (b)(6), item (b)(4), lot 868197; therapy date (b)(6) 2017.Item (b)(4), lot 891745, therapy date (b)(6) 2017.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: 3002806535-2017-01213 and 3002806535-2017-01214.

Event Description

It was reported that a patient underwent an initial knee procedure and subsequently the patient was revised due to unknown reason.

Manufacturer Narrative

(b)(4).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.

• Brand Name: OXFORD UNI TIB BRG MED SZ5
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7132880
• MDR Text Key: 95322634
• Report Number: 3002806535-2017-01215
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

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 Expiration Date: 11/30/2009
• Device Model Number: N/A
• Device Catalogue Number: 154628
• Device Lot Number: 848380
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 05/09/2018
• Supplement Dates FDA Received: 05/09/2018
• 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: 82 YR