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U.S. Department of Health and Human Services

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

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BIOMET UK LTD. OXF UNI TIB TRAY SZ D RM PMA; OXFORD PARTIAL KNEE SYSTEM Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Information (3190)
Event Date 12/08/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial report.Unique identifier (udi) number: (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation due to their hospital policy.Once the investigation has been completed, a supplemental mdr will be submitted.Concomitant medical products: medical product: oxf twin-peg cmntd fem md pma, catalog: 161469, lot: 858740.Medical product: oxf anat brg rt md size 6 pma, catalog:159578, lot: 592020.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 on (b)(6) 2020.Subsequently, a revision procedure due to tibial subsidence was performed on (b)(6) 2020.
 
Manufacturer Narrative
(b)(4).This report to be voided.On jan 08, 2021, we identified that (b)(4) is duplicate of (b)(4).(b)(4) is to be made not a complaint, therefore, this report is to be voided.The reported event in respect of (b)(4) is reported under 3002806535-2020-00548 and 3002806535-2020-00548-1.
 
Event Description
It was reported that a patient underwent an initial knee arthroplasty on (b)(6), 2020.Subsequently, a revision procedure due to tibial subsidence was performed on (b)(6) 2020.
 
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Brand Name
OXF UNI TIB TRAY SZ D 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 Key11071286
MDR Text Key223599623
Report Number3002806535-2020-00559
Device Sequence Number1
Product Code NRA
UDI-Device Identifier050192793888912
UDI-Public(01)050192793888912(17)290130(
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 12/24/2020
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 Number154725
Device Lot Number134570
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received12/24/2020
Supplement Dates Manufacturer Received01/08/2021
Supplement Dates FDA Received01/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight92
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