MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 4 PMA; KNEE PROSTHESIS

Model Number N/A

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: oxf uni tib tray sz e lm pma catalog #: 154726 lot #: 765110, medical product: oxf twin-peg cmntd fem lg pma catalog #:161470 lot #: 529580.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00588, 3002806535-2019-00587.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 unknown reason.

Manufacturer Narrative

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

Event Description

Revision due to lateral wear.

Event Description

It was reported that a patient underwent revision due to lateral wear.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found in relation to this reported event.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 ANAT BRG LT LG SIZE 4 PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8770626
• MDR Text Key: 150368130
• Report Number: 3002806535-2019-00586
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786015
• UDI-Public: 05019279786015
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2022
• Device Model Number: N/A
• Device Catalogue Number: 159555
• Device Lot Number: 079140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 07/10/2019; 08/15/2019
• Supplement Dates FDA Received: 07/19/2019; 08/21/2019
• 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 Age: 69 YR