MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ C LM PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Collapse (1099)

Patient Problem Collapse (2416)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Unique identifier (udi) number: (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial left knee procedure.Subsequently, the patient was revised due to subsided tibial component.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Associated products: medical product:saw blades strykerâ® system 7, 6, 5, 4, 2000 & ehd item number: 506298 lot #: 278923 medical product: oxf anat brg lt md size 4 pma item number: 159548.Lot #: 878220 medical product: oxf twin-peg cmntd fem md pma item number: 161469 lot #: 502190 reported event was confirmed by review of x-rays provided.Device history record (dhr) was reviewed and no discrepancies were found.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 that a patient underwent an initial left knee procedure.Subsequently, the patient was revised due to subsided tibial component.

• Brand Name: OXF UNI TIB TRAY SZ C LM PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8304479
• MDR Text Key: 134979877
• Report Number: 3002806535-2019-00084
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• 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: 154722
• Device Lot Number: 803650
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2019
• 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
• Patient Weight: 95