MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM LG PMA; KNEE PROTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Concomitant medical products: medical product: oxf uni tib tray sz f rm pma, catalog #: 154776, lot #: 464000.Medical product: anat brg rt lg size 3 pma, catalog #: 159582, lot #: 825700.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00074, 3002806535-20120-00072.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 a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure was performed due to pain.

Manufacturer Narrative

(b)(4).D11: medical product: oxf anat brg rt lg size 3 pma, catalog #: 159582, lot #: 825700; medical product: oxf uni tib tray sz f rm pma, catalog #: 154776, lot #: 464000.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00072-1, 3002806535-2020-00074-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.It is not possible to determine the cause of the pain without surgical notes, post-primary x-rays and patient information such as activity levels and bmi, therefore the root cause of the issue could not be determined.The outcome of this complaint is considered to be within the severity of the rmr.The manufacturing history records (mhrs) for the oxford partial knee femoral component, tibial tray and anatomical bearing have been checked and verify that the components were manufactured and sterilised in accordance with the applicable specifications.A review of the complaint database over the last 3 years has found 1 similar complaint for this item code 159582, 2 similar complaints for this item code 161470 and no similar complaints found for the item 154776.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 a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure was performed due to pain.

• Brand Name: OXF TWIN-PEG CMNTD FEM LG PMA
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9693767
• MDR Text Key: 241260683
• Report Number: 3002806535-2020-00073
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• PMA/PMN Number: P01004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• 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: 161470
• Device Lot Number: 700850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2020
• 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