MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ A LM; OXFORD CEMENTLESS TIBIAL TRAYS

Catalog Number 166845

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product - oxf anat brg lt md size 3 pma, item 159547, lot 6193792.Therapy date - (b)(6) 2018.Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2018-01202.

Event Description

It was reported that the patient underwent an initial left knee arthroplasty.Subsequently, the patient was revised due to tibial loosening.Tibial component and bearing were revised.

Event Description

It was reported that the patient underwent an initial left knee arthroplasty.Subsequently, the patient was revised due to tibial loosening.Tibial component and bearing were revised.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of x-rays provided.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.

• Brand Name: OXF UNI CMNTLS TIB SZ A LM
• Type of Device: OXFORD CEMENTLESS TIBIAL TRAYS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8096561
• MDR Text Key: 128103441
• Report Number: 3002806535-2018-01201
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 166845
• Device Lot Number: 6060390
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2019
• 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