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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ D LM; KNEE PROSTHESIS

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BIOMET UK LTD. OXF UNI CMNTLS TIB SZ D LM; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 08/07/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4.) report source, foreign - event occurred in the (b)(6).The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient underwent a revision of oxford unicompartmental tibial bearing to a vanguard m fixed bearing due to an unknown reason.Subsequently, the surgeon implanted the wrong side bearing.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 a revision of oxford unicompartmental tibial bearing to a vanguard m fixed bearing due to an unknown reason.Subsequently, the surgeon implanted the wrong side bearing.
 
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Brand Name
OXF UNI CMNTLS TIB SZ D LM
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key8895914
MDR Text Key154406763
Report Number3002806535-2019-00680
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 foreign,health professional
Type of Report Initial,Followup
Report Date 09/14/2019
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 Number166576
Device Lot Number6043211
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/07/2019
Initial Date FDA Received08/15/2019
Supplement Dates Manufacturer Received09/09/2019
Supplement Dates FDA Received09/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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