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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING; KNEE PROTHESIS

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BIOMET UK LTD. UNKNOWN OXFORD BEARING; KNEE PROTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 12/17/2019
Event Type  Injury  
Manufacturer Narrative
(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.Concomitant medical products: medical product: unknown tibial component, catalog #: unknown, lot #: unknown, medical product: unknown femoral component, catalog #: unknown lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00020, 3002806535-2020-00018.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.
 
Event Description
It was reported that a patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure due to unknown reason was performed.
 
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: 3002806535-2020-00018-1 3002806535-2020-00020-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.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 left knee arthroplasty.Subsequently, a revision procedure due to unknown reason was performed.
 
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Brand Name
UNKNOWN OXFORD BEARING
Type of Device
KNEE PROTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key9586208
MDR Text Key174866960
Report Number3002806535-2020-00019
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
PMA/PMN Number
P01004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/23/2020
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 NumberUNK OXFORD BEARING
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/18/2019
Initial Date FDA Received01/14/2020
Supplement Dates Manufacturer Received04/22/2020
Supplement Dates FDA Received04/23/2020
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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