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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 4 PMA; KNEE PROSTHESIS

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BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 4 PMA; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 12/13/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4) multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00037, 3002806535-2019-00038.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 left knee replacement procedure.Subsequently, the patient was revised due to unknown reasons.
 
Manufacturer Narrative
(b)(4).Medical product: oxf twin-peg cmntd fem md pma catalog #: 161469; log #: 183080.Medical product: oxf uni tib tray sz c lm pma catalog #: 154722; log #: 242190.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 an initial left knee procedure.Subsequently, the patient was revised due to unknown reasons.
 
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Brand Name
OXF ANAT BRG LT MD SIZE 4 PMA
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key8234872
MDR Text Key132761609
Report Number3002806535-2019-00039
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 health professional
Type of Report Initial,Followup
Report Date 06/20/2019
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 Expiration Date12/30/2020
Device Model NumberN/A
Device Catalogue Number159548
Device Lot Number463430
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/14/2018
Initial Date FDA Received01/10/2019
Supplement Dates Manufacturer Received06/19/2019
Supplement Dates FDA Received06/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age64 YR
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