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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Arthritis (1723); Pain (1994); Synovitis (2094)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign ¿ events occurred in (b)(6).Report source, literature - xue, h.Et al (2017).Up to twelve year follow-up of the oxford phase three unicompartmental knee replacement in china: seven hundred and eight knees from an independent centre.International orthopaedics, 41(8),1571¿1577.Doi 10.1007/s00264-017-3492-4.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-00655, 3002806535-2017-00656.

Event Description

It has been reported in a journal article that a patient underwent a revision due to persistent pain 4.1 years after the initial procedure.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN OXFORD KNEE BEARING
• 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: 6784139
• MDR Text Key: 82419381
• Report Number: 3002806535-2017-00654
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2017
• 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
• Treatment: UNKNOWN OXFORD FEMORAL COMPONENT; UNKNOWN OXFORD TIBIAL COMPONENT
• Patient Outcome(s): Hospitalization; Required Intervention