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

Model Number N/A

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Information (3190)

Event Date 07/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown oxford knee femoral component, part/lot unknown; unknown oxford knee tibial tray, part/lot unknown.Report source, foreign ¿ events occurred in (b)(6).Report source, literature - xu, t., lao, y., wang, j., liu, f., xiao, l.And tong, p.(2017), mid-term results of oxford phase-3 medial unicompartmental knee arthroplasty for medial arthritis in chinese patients.Anz journal of surgery, 87: 287¿290.Doi: 10.1111/ans.13764.The devices were not returned for evaluation.No further information has been made available.The reported event was unable to be confirmed due to limited information received from the customer.A review of device history records (dhr) 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 reports: 3002806535-2017-00825, 3002806535-2017-00826.Not returned to manufacturer.

Event Description

It was reported in a journal article that a patient was revised to address asceptic loosening.No further information is available at this time.

• Brand Name: UNKNOWN OXFORD KNEE TIBIAL TRAY
• 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: 6789956
• MDR Text Key: 82579470
• Report Number: 3002806535-2017-00826
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Patient Outcome(s): Hospitalization; Required Intervention