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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); No Information (3190)

Event Type  Death  

Manufacturer Narrative

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.Initial reporter - hamilton, et al."evidence-based indications for mobile-bearing unicompartmental knee arthroplasty in a consecutive cohort of thousand knees," the journal of arthroplasty xxx (2017) 1-7.

Event Description

It was reported in a journal article that 44 patients died and 23 patients underwent revision procedures.No further information is available.

• Brand Name: UNKNOWN OXFORD
• 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: 6377356
• MDR Text Key: 69048396
• Report Number: 3002806535-2017-00110
• Device Sequence Number: 0
• Product Code: NRA
• Reporter Country Code: UK
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention