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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD TIBIAL COMPONENT; KNEE PROSTHESIS

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BIOMET UK LTD. UNK OXFORD TIBIAL COMPONENT; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problems Bone Fracture(s) (1870); Pain (1994)
Event Date 09/26/2019
Event Type  Injury  
Manufacturer Narrative
(b)(6).Report source: (b)(6).Concomitant medical products: medical product: unk oxford bearing catalog #: not reported lot #: not reported, medical product: unk oxford femoral component catalog #: not reported lot #: not reported.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
 
Event Description
It was reported by the sales representative that a patient underwent initial knee arthroplasty on (b)(6) 2019.Subsequently, the tibial fractured with subsidence of the component.This was identified with x-rays after the patient complained about pain.A revision surgery is planned.
 
Event Description
It was reported by the sales representative that a patient underwent initial knee arthroplasty.Subsequently, the tibial fractured with subsidence of the component.This was identified with x-rays after the patient complained about pain.A revision surgery is planned.
 
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.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Radiological images: three anteroposterior radiographs were provided for analysis with (b)(4): one pre-primary surgery; one post-primary surgery; and one pre-revision (after fracture of tibial plateau).Exact dates of the radiographs have not been provided.In the post-primary x-ray, the tibial tray is overhanging from the medial side of the tibial plateau.The oxford partial knee surgical technique states that the medial edge of the tibial tray should be flush with (or have less than 2 mmm overhang from) the medial edge of the tibial plateau.The zper states that the surgical technique for the product was utilised.The post-primary x-ray suggests that a thick bearing has been used, which may have required a more distal tibial bone resection than necessary.This cannot be confirmed without part and lot numbers, mediolateral x-rays, surgical notes and additional information related to patient¿s post-operative activity level.Root cause was unable to be determined.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.
 
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Brand Name
UNK OXFORD TIBIAL COMPONENT
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key9436659
MDR Text Key169808014
Report Number3002806535-2019-00914
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 company representative,foreig
Type of Report Initial,Followup
Report Date 12/19/2019
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? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/25/2019
Initial Date FDA Received12/09/2019
Supplement Dates Manufacturer Received11/30/2019
Supplement Dates FDA Received12/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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