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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM MD PMA; OXFORD PARTIAL KNEE SYSTEM
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BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM MD PMA; OXFORD PARTIAL KNEE SYSTEM Back to Search Results
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 uni tib tray sz c rm pma, catalog #: 154723, lot #:496500; 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: 3002806535-2020-00402, 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.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00402-1, 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: jan 2017 to dec 2020.Complaint data time period: (b)(6) 2017 to (b)(6) 2021 (current date).Item 154723: number of sales: (b)(4), number of complaints: (b)(4), complaint ratio: (b)(4), occurrence score: (b)(4), this score is in line with the risk file.Item 159576: number of sales: (b)(4), number of complaints: (b)(4), complaint ratio: (b)(4), occurrence score: (b)(4), this score is in line with the risk file.Item 161469: number of sales: (b)(4), number of complaints: (b)(4) (only the initiating complaint concludes a cement issue), complaint ratio: (b)(4), occurrence score: (b)(4).This score is not in line with the risk file, however, the additional (b)(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:(b)(4), complaint ratio for hazard: (b)(4), occurrence score: (b)(4), 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.
 
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.
 
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)(6).This final / follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, a4, b4, b5, b7, d8, g3, g6, h1, h2, h10.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00402-2, 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.
 
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Brand Name
OXF TWIN-PEG CMNTD FEM MD 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 Key10493115
MDR Text Key205660553
Report Number3002806535-2020-00403
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279438242
UDI-Public05019279438242
Combination Product (y/n)N
PMA/PMN Number
P010014
Number of Events Reported1
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
Date FDA Received09/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number161469
Device Lot Number645190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2020
Was the Report Sent to FDA? No
Date Manufacturer Received03/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight86
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