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

Model Number N/A

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

Patient Problem No Information (3190)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by the hospital that a patient underwent an initial oxford knee replacement procedure.Subsequently, the hospital reported an unknown event has occurred.Further information has been requested.

Event Description

It was reported by a sales representative that a surgeon implanted a left bearing, instead of the right.There has been no further action taken on this incident.

Manufacturer Narrative

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

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.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 a sales representative that a surgeon implanted a left bearing, instead of the right.There has been no further action taken on this incident.

• Brand Name: OXF ANAT BRG LT SM SIZE 4 PMA SML SZ 4
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8771144
• MDR Text Key: 150391045
• Report Number: 3002806535-2019-00593
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279785872
• UDI-Public: 05019279785872
• Combination Product (y/n): N
• PMA/PMN Number: P010014/S028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2019

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: 02/18/2024
• Device Model Number: N/A
• Device Catalogue Number: 159541
• Device Lot Number: 6488613
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 07/09/2019; 08/28/2019
• Supplement Dates FDA Received: 07/17/2019; 09/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR