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

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00016 and 0001825034-2019-00017.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent initial left knee arthroplasty.Subsequently, the patient was revised due to loosening.

Event Description

It was reported that the patient underwent initial left knee arthroplasty.Subsequently, the patient was revised due to loosening.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of x-rays provided.Post-primary and pre-revision radiographs are required in order to provide a more detailed assessment of implant sizing, positioning and alignment.The complaint description does not state which specific component(s) became loose and the revised components have not been provided for examination.The part details for the revised components have also not been provided and therefore the relevant manufacturing history records (mhrs) were unable to be checked.The root cause of revision cannot be determined with the limited information provided.Further radiographic, surgical and patient information, as well as provision of the revised components, is required in order to determine the cause of revision.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: UNKNOWN OXFORD FEMORAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8222000
• MDR Text Key: 132221266
• Report Number: 3002806535-2019-00018
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK OXFORD FEM COMPONENT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 04/02/2019
• 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