MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Associate product: medical product: unk oxford tibial component, catalog #:unknown, lot #: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Journal article: femoral migration of the cementless oxford which caused the bearing dislocation by hiroshi inui , shuji taketomi , ryota yamagami , kohei kawaguchi , sakae tanaka.Case report: in an (b)(6)-year-old woman, bearing dislocation occurred 13 months postoperatively because of femoral migration that was resolved with an revision surgery to cemented component and thicker mobile insert.Attempts have been made and no further information has been provided at this time.

Manufacturer Narrative

(b)(4).Follow up report as we omitted to state that multiple mdr report were filed for this event.D9: associate products: medical product: unk oxford femoral component, catalog #:unknown, lot #: unknown; medical product: unk oxford tibial component, catalog #:unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00154.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Journal article: femoral migration of the cementless oxford which caused the bearing dislocation by hiroshi inui, shuji taketomi , ryota yamagami, kohei kawaguchi, sakae tanaka.Case report: in an 82-year-old woman, bearing dislocation occurred 13 months postoperatively because of femoral migration that was resolved with an revision surgery to cemented component and thicker mobile insert.Attempts have been made and no further information has been provided at this time.

Event Description

Journal article: femoral migration of the cementless oxford which caused the bearing dislocation by hiroshi inui, shuji taketomi, ryota yamagami, kohei kawaguchi, sakae tanaka.Case report: in an 82-year-old woman, bearing dislocation occurred 13 months postoperatively because of femoral migration that was resolved with an revision surgery to cemented component and thicker mobile insert.Attempts have been made and no further information has been provided at this time.

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 report: 3002806535-2021-00154-1 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: UNKNOWN OXFORD BEARING
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11775444
• MDR Text Key: 248985864
• Report Number: 3002806535-2021-00153
• Device Sequence Number: 1
• Product Code: NRA
• 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,Followup
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• 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 BEARING
• Was Device Available for Evaluation?: No
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR