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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 Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problem Arthritis (1723)
Event Date 10/21/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical products: medical product: 159575, catalog #: oxf anat brg rt md size 3 pma, lot #: 099540, medical product: 154721, catalog #: oxf uni tib tray sz b rm pma, lot #: 016700.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00481, 3002806535-2020-00483.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 right knee arthroplasty on (b)(6) 2018.Subsequently, the patient developed arthritis on the lateral side, and the progression lead to needing a total knee replacement on (b)(6) 2020.
 
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: 3002806535-2020-00481-1, 3002806535-2020-00483-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with the item and lot combination.A review of the complaint database over the last 3 years has found 2 similar complaints reported with the item 159575.A review of the complaint database over the last 3 years has found 10 similar complaints reported with the item 161469.A review of the complaint database over the last 3 years has found 3 similar complaints reported with the item 154721.No trends were identified with respect to similar complaints.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports revision due to disease progression.A risk assessment has not been performed for the reported event as disease progression is not device related.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
 
Event Description
It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2018.Subsequently, the patient developed arthritis on the lateral side, and the progression lead to needing a total knee replacement on (b)(6) 2020.
 
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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 Key10852180
MDR Text Key216632330
Report Number3002806535-2020-00482
Device Sequence Number1
Product Code NRA
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
Report Date 11/26/2020
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 Model NumberN/A
Device Catalogue Number161469
Device Lot Number222320
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/21/2020
Initial Date FDA Received11/17/2020
Supplement Dates Manufacturer Received11/26/2020
Supplement Dates FDA Received11/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEEH10
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age49 YR
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