MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD FEMORAL COMPONENT; KNEE ARTHROPLASTY

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Concomitant medical products: customer has indicated that the product will not be returned to zimmer biomet for investigation, as it the hospital would not return the explanted product multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00465, 3002806535-2021-00466.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Hospital not returning device.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on an unknown date.Subsequently, a revision procedure due to considerable pain was performed on (b)(6) 2021, when the patient was revised to a persona total knee.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: product has not been returned for evaluation.The item and lot number have not been provided.X-rays or medical notes have not been provided.The investigation has been limited to the information provided.A historical search could not be performed as the item and lot number have not been provided.These devices are used for treatment.Not enough information has been provided to determine if all implants are compatible.A dhr review or a review of recalls could not be performed as the item and lot number have not been provided.The likely condition of the devices when they left zimmer biomet could not be determined as the item and lot number has not been provided.The root cause of the reported event can not be determined with the information provided no corrective action required at this time as the root cause of the reported event has not been determined.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00465-1, 3002806535-2021-00466-1.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported, that: a patient underwent an initial right knee arthroplasty on an unknown date.Subsequently, a revision procedure due to considerable pain was performed on (b)(6) 2021, when the patient was revised to a persona total knee.

• Brand Name: UNK OXFORD FEMORAL COMPONENT
• Type of Device: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12688758
• MDR Text Key: 278112345
• Report Number: 3002806535-2021-00467
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK OXFORD FEMORAL COMPONENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female