MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD TIBIAL COMPONENT; KNEE PROTHESIS

Model Number N/A

Device Problems Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.Medical product: unknown femoral component, catalog # unknown, lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00215.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent right partial knee arthroplasty on an unknown date in (b)(6) 2018.Subsequently, approximately one year post op patient started to experience increasing pain, difficulty walking, instability, and clunking noise and feeling.Surgeon has diagnosed patient with mechanical loosening.Patient is scheduled for revision to total knee (b)(6) 2020.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: a1, b4, b5, d10, g4, g7, h1, h2, h3, h6, h10.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00215-1.The product has not been returned to biomet for evaluation, therefore, a thorough investigation has not been possible.We have not been provided with x-rays or any supporting documentation which could provide additional information.The product and lot number identification necessary to review manufacturing history and the complaint history was not provided.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.No corrective or preventive actions are deemed necessary.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly h3 other text : product has not been returned.

Event Description

It was reported that patient underwent right partial knee arthroplasty on an unknown date in (b)(6) 2018.Subsequently, approximately one year post op patient started to experience increasing pain, difficulty walking, instability, and clunking noise and feeling.Surgeon has diagnosed patient with mechanical loosening.Patient is scheduled for revision to total knee (b)(6) 2020.

• Brand Name: UNK OXFORD TIBIAL COMPONENT
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9928113
• MDR Text Key: 195272772
• Report Number: 3002806535-2020-00214
• Device Sequence Number: 1
• Product Code: HRY
• 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: other
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• 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: UNK OXFORD TIBIAL COMPONENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2020
• 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