MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 8 PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00086, 3002806535-2019-00087.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that the patient underwent initial left knee procedure.Subsequently patient was revised due to unknown reasons.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Associated products: medical product: oxford resection 3pk strk 6 h item number: 506124.Lot # 947274.Medical product:sig m pka gde/mdl set lge ph3 catalog: 42-411563 lot #: 114047.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 that the patient underwent initial left knee procedure.Subsequently patient was revised due to unknown reasons.

• Brand Name: OXF ANAT BRG LT LG SIZE 8 PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8309736
• MDR Text Key: 135141678
• Report Number: 3002806535-2019-00088
• 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: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2017
• Device Model Number: N/A
• Device Catalogue Number: 159559
• Device Lot Number: 2878910
• 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