MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ C RM PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report: unique identifier (udi) number: (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: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #:645190; medical product: oxf anat brg rt md size 4 pma, catalog #: 159576, lot #: 513300.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00403, 3002806535-2020- 00404.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee arthroplasty.Subsequently, a revision procedure took place due to implant fracture.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6)2016.Subsequently, a revision procedure took place on (b)(6)2020 due to implant fracture.Patient experienced pain on (b)(6)2020.No trauma to the knee.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00403-1, 3002806535-2020-00404-1.The event reports that revision surgery was required due to pain and implant fracture.The complaint has been confirmed following review of the returned implant, which confirmed the femoral component had fractured into two fragments.The small anterior peg of the component had also detached from the main body.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A complaint history review identified 4 additional complaints for implant fracture for item number 161469, however none of them were confirmed to be due to an incorrect cementing technique.No further similar complaints were identified for item 154723 and 159576.A complaint history review identified no similar complaints for the same lot numbers.This device is used for treatment.The likely condition of the device when it left zimmer biomet is conforming to specification.The likely cause of the reported event is incorrect cementing technique used by the user during surgery.No corrective action required as no design or manufacturing deficiency has been identified and the occurrence rate of the hazard is in line with the risk file.Risk assessment: hazard of user error: incorrect cementing technique.This hazard includes a harm of non-functioning joint which has a severity score of 3 (prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure) and an occurrence rate of 2 (1 in 10,000 to 1 in 100,000).The actual severity of the reported event is s-3 (requires surgical intervention), and the calculated occurrence for all similar events in the last 3 years are in line with this risk file.Occurrence assessment: the occurrence rate has been calculated using sales and complaint for a time period of 3 calendar years before the notification date to current date, for each item number reported (154723, 159576 and 161469).Sales data time period: (b)(6)2017 to (b)(6)2020 complaint data time period: (b)(6)2017 to (b)(6)2021 (current date).Item 154723: number of sales: 29,907 number of complaints: 1 complaint ratio: 1: 29,907 occurrence score: 2 this score is in line with the risk file.Item 159576: number of sales: (b)(4).Number of complaints:1 complaint ratio: 1: 26,407 occurrence score: 2 this score is in line with the risk file.Item 161469: number of sales: (b)(4) number of complaints: 5 (only the initiating complaint concludes a cement issue) complaint ratio: 5:29,658 = 1 in 5,932 occurrence score: 3.This score is not in line with the risk file, however, the additional 4 complaints identified did not determine a hazard of incorrect cementing technique (no cause was identified), therefore, it would not be appropriate to assign these events to the same line.Multiple other lines cover a harm of non functioning joint with a severity score of 3.The occurrence rate has been recalculated using complaints that could be assigned to the applicable line: number of complaints for hazard:1 complaint ratio for hazard: 1:29,658 occurrence score: 2 this score is in line with the risk file.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.

Manufacturer Narrative

(b)(4).This final / follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00403-2, 3002806535-2020-00404-2.Additional information received: initial date of implantation: (b)(6) 2016.Surgeon: (b)(6).Hospital: (b)(6).Patient information: initials: (b)(6), dob (b)(6) 1947, height: 5.4, weight: 190 lbs, active.Additional information received have been reviewed and determine that they do not alter the outcome of the investigation.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 knee arthroplasty on (b)(6) 2016.Subsequently, a revision procedure took place on (b)(6) 2020 due to implant fracture.Patient experienced pain on (b)(6) 2020.No trauma to the knee.

• Brand Name: OXF UNI TIB TRAY SZ C RM PMA
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10493109
• MDR Text Key: 205659679
• Report Number: 3002806535-2020-00402
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388899
• UDI-Public: 05019279388899
• 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,Followup
• Report Date: 04/07/2021

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 Model Number: N/A
• Device Catalogue Number: 154723
• Device Lot Number: 496500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 01/27/2021; 03/11/2021
• Supplement Dates FDA Received: 01/27/2021; 04/07/2021
• 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: 86