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

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.The product has not been returned to the manufacturer.Medical product: unk oxford bearing component, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00161 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Journal case report: femoral migration of the cementless oxford which caused the bearing dislocation.Authors: hiroshi inui , shuji taketomi , ryota yamagami , kohei kawaguchi , sakae tanaka - national center for biotechnology information, maryland, usa.The journal reported that in a 52-year-old man, first bearing dislocation occurred 7 months postoperatively.Five months after revising the insert to a thicker one, another dislocation occurred mainly because of the femoral migration.Eventually, a revision to total knee arthroplasty was necessary.This complaint is for the 2nd revision of dislocation due to femoral migration.

Event Description

Journal case report: femoral migration of the cementless oxford which caused the bearing dislocation.Authors: hiroshi inui , shuji taketomi , ryota yamagami , kohei kawaguchi , sakae tanaka - national center for biotechnology information, maryland, usa.The journal reported that in a 52-year-old man, first bearing dislocation occurred 7 months postoperatively.Five months after revising the insert to a thicker one, another dislocation occurred mainly because of the femoral migration.Eventually, a revision to total knee arthroplasty was necessary.This complaint is for the 2nd revision of dislocation due to femoral migration.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: biomet uk ltd have attempted to contact the journal article author, however, no additional information is received.The product has not been returned to biomet uk ltd for evaluation, therefore, a thorough investigation has not been possible.In addition, we have not been provided with any supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.The journal article believes that the reason for the failure was osteoporosis and early return to high performance activity.Reported event was unable to be confirmed due to limited information received from the customer.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00161-1.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.

• 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
• MDR Report Key: 11782638
• MDR Text Key: 249973663
• Report Number: 3002806535-2021-00160
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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: N/A
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2021
• 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: 52 YR