MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PARTIAL KNEE ANATOMIC MENISCAL BEARING SIZE MEDIUM 3MM; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Sleep Dysfunction (2517)

Event Date 10/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: oxford partial knee twin peg femoral component size medium catalog #: 161469 lot #: 502190, oxford partial knee right medial tibial tray size b catalog #: 154721 lot #: 814690.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00402, 3002806535-2019-00403.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that the patient underwent a right knee arthroplasty revision approximately ten (10) months post-operatively due to knee, hip, back and neck pain accompanied by headaches and sleeplessness.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Visual examination of the femoral component showed the presence of light scratches on the anterior section of the articulating surface.The cement pocket was covered by uneven but well attached cement, which overhung from it in some places.The articulating surface of the tibial tray presented some longitudinal scratches in the a/p direction, as well as some deep, random scratches, which may have been caused by third body particles present in the joint space such as osteophytes or bone cement fragments, or due to implant removal during revision surgery.Cement was only present medially on the inferior surface of the tibial tray, although it is not clear whether part of the cement mantle was removed from other regions during revision.Implant examination suggests that there may have been issues with cement fixation, however the exact root cause of the reported event could not be determined.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 is reported that the patient underwent a right knee arthroplasty revision approximately ten (10) months post-operatively due to knee, hip, back and neck pain accompanied by headaches and sleeplessness.No additional patient consequences were reported.

• Brand Name: OXFORD PARTIAL KNEE ANATOMIC MENISCAL BEARING SIZE MEDIUM 3MM
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8543129
• MDR Text Key: 142870517
• Report Number: 3002806535-2019-00401
• 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: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2022
• Device Model Number: N/A
• Device Catalogue Number: 159575
• Device Lot Number: 365570
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2019
• 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
• Patient Weight: 113