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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB BRG MED SZ6; KNEE PROSTHESIS

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BIOMET UK LTD. OXFORD UNI TIB BRG MED SZ6; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); No Information (3190)
Event Date 06/28/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: oxford uni femoral md item #: 154601 lot #: 1230424, medical product: oxford uni tib tray44x28 llrm item #: 154610 lot #: 1157476, associated product: cobalt-g hv bone cement 40gm b.Item #: 402433.Lot #: 974350.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00560, 3002806535-2019- 00562.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 right knee arthroplasty.Subsequently, the patient is schedules to be revised due to her knee locking up.
 
Event Description
It was reported that a patient underwent right knee arthroplasty.Subsequently, the patient is scheduled to be revised due pain and knee locking up.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, h1, h2, h3, h6.The visual investigation confirmed the reported event.The cement mantle was found to be uneven but well attached to the tibial and femoral components, covering most of the non - articulatingsurface and slightly overhanging from the cement pocket.There is little evidence of bone integration on tibial tray and the femoral component.There are light scratches on the articulating surface of the femoral component.Deep scratches are visible on the articulating surfaces of the tibial tray, the surface damage could have appeared during implant removal.Considering that the implant was in use for over 12 years the polyethylene bearing is in overall good condition.Some pitting and light starches are observed on the bearing surface, this indicates that there might have been some third bodies present in the joint space, however this cannot be confirmed without radiographic images.The root cause of the reported event could not be determined from the information provided in the complaint.Device history record (dhr) was reviewed and no discrepancies were found.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 patient underwent right knee arthroplasty.Subsequently, revision surgery performed due pain.
 
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Brand Name
OXFORD UNI TIB BRG MED SZ6
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key8751949
MDR Text Key149757256
Report Number3002806535-2019-00563
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279388356
UDI-Public05019279388356
Combination Product (y/n)N
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 01/31/2020
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? Yes
Device Operator Health Professional
Device Expiration Date05/31/2011
Device Model NumberN/A
Device Catalogue Number154629
Device Lot Number1183029
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/20/2019
Initial Date FDA Received07/02/2019
Supplement Dates Manufacturer Received09/17/2019
01/28/2020
Supplement Dates FDA Received09/17/2019
01/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Weight100
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