MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZA RM/LL PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pulmonary Embolism (1498)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).This event was initially reported under biomet orthopedics llc facility number, report reference: 0001825034-2019-01277.Multiple mdr reports were filed for this event, please see associated report: 3002806535 -2019 - 00299, 3002806535 -2019 - 00300.Concomitant medical products: oxf twin-peg cmntd fem sm pma item# 161468 lot# 790270, oxf anat brg rt sm size 3 pma item# 159568 lot# 428720.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.Remains implanted.

Event Description

It was reported that patient underwent initial knee arthroplasty and subsequently the patient suffered pulmonary embolus.There is no additional information at this time.

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 was reported that patient underwent initial knee arthroplasty and subsequently the patient suffered pulmonary embolus.

Manufacturer Narrative

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

Event Description

It was reported that patient underwent initial knee arthroplasty and subsequently the patient suffered pulmonary embolus in both lungs.

• Brand Name: OXF UNI TIB TRAY SZA RM/LL PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8455106
• MDR Text Key: 139955603
• Report Number: 3002806535-2019-00298
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• 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: 154719
• Device Lot Number: 2154719
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2019
• 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