MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD TIBIAL TRAY RM; KNEE PROTHESIS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown oxford single peg femur #item unknown #lot unknown.Oxf anat brg rt lg size 3 pma item#159582 #lot 1332637.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Unknown tibial tray: part and lot identification are necessary for review of device history records, neither were provided.Device is used for treatment.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: here is advanced lateral compartment osteoarthritis.A joint effusion is noted.Bone quality is osteopenic.There is no evidence of joint overstuffing, but this would be best evaluated by earlier radiographs at the time of surgery.The current valgus alignment of the medial unicompartmental arthroplasty could lead to lateral compartment stress and osteoarthritis.The root cause of the reported issue is attributed to disease progression.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00466, 3002806535-2022-00467.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that patient underwent revision due to lateral knee pain.Right knee total knee arthroplasty was performed during the operation.No further event information available at the time of this report.

• Brand Name: UNKNOWN OXFORD TIBIAL TRAY RM
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15813102
• MDR Text Key: 303800064
• Report Number: 3002806535-2022-00468
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male