MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA; KNEE PROSTHESIS

Model Number N/A

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Arthritis (1723); No Code Available (3191)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: oxf twin-peg cmntd fem md pma catalog #: 161469 lot #: 760500, medical product: oxf uni tib tray sz d rm pma catalog #: 154725 lot #: 556090.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00942, 3002806535-2019-00943.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure due to progressive osteoarthritis and instability was performed.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure due to progressive osteoarthritis and instability was performed.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00942-1, 3002806535-2019-00943-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Radiographs of the right knee reveal severe joint space narrowing, marginal bone spur, subchondral cyst formation, osteophyte formation.Moderate arthritis is noted in the patellofemoral compartment.Severe arthritic changes are noted in the lateral compartment.Post operative radiographs reveal good prosthesis alignment, no evidence of prosthesis loosening.The information available suggests that the oxford partial knee was well-fixed at the time of revision and functioned as intended.The manufacturing history records for the oxford partial knee tibial tray, femoral component and anatomical bearing have been checked and verify that the components were manufactured and sterilised in accordance with the applicable specifications.The surgical notes suggest that disease progression of osteoarthritis in the lateral compartment and patellofemoral compartment have contributed to the revision in this instance.Instability was also mentioned as a contributing factor, however the root cause of this cannot be established with the available information, but may have been related to the patient¿s soft tissue laxity as notes from the primary surgery confirm there was no tendency towards subluxation at all.A review of the complaint database over the last 3 years has found 1 similar complaint for the item code 159576, 5 similar complaints for the item code 161469 and 1 similar complaint found for the item 154725.There were no trends identified from the complaint history review.No same lot numbers, no same hospitals and there are no trends in the cause.In most cases of similar complaints, the cause could not be established.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.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.

• Brand Name: OXF ANAT BRG RT MD SIZE 4 PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9502519
• MDR Text Key: 172190731
• Report Number: 3002806535-2019-00941
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: 773900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 03/13/2020
• Supplement Dates FDA Received: 03/20/2020
• 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
• Patient Weight: 205