MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ B LM

Catalog Number 166572

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in the (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the hospital that a patient underwent an initial left knee arthroplasty.Subsequently, a revision was performed due to osteosyntheses.

Manufacturer Narrative

(b)(4).The follow up report is being submitted to relay additional information.Reported event was confirmed by radiographs.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.

Event Description

It was reported by the hospital that a patient underwent an initial left knee arthroplasty.Subsequently, a revision was performed due to ostesyntheses.

• Brand Name: OXF UNI CMNTLS TIB SZ B LM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7869470
• MDR Text Key: 119987719
• Report Number: 3002806535-2018-01070
• 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: 12/04/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 166572
• Device Lot Number: 6267384
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: 11/30/2018
• Supplement Dates FDA Received: 12/04/2018
• 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
• Patient Age: 72 YR
• Patient Weight: 75