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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXF TIBIAL

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BIOMET UK LTD. UNKNOWN OXF TIBIAL Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
It was reported, that: on 08 sep 2021, a journal article was retrieved by our clinical team that reported a study from (b)(6) which looked at the effect of age on the outcomes of cementless mobile-bearing unicompartmental knee replacements.This study analysed the effect of age at the surgery on the mid to long term clinical outcomes of 1000 cementless ukr.Patients were categorised into four age groups (< 55, 55 to < 65, 65 to < 75 and = 75 years).Implant survival was assessed using endpoints reoperation, revision and major revision requiring revision knee replacement components.Functional outcomes were assessed.Complaint thirteen: the study reports revision ukr due to tibial avascular necrosis.Patient outcome: revision.
 
Manufacturer Narrative
(b)(4).This is a combined initial/final report and is being submitted to relay information.Report source, foreign - event occurred in (b)(6).The client has indicated that the product will not be returned to zimmer biomet for an investigation.Complaint summary: the product has not been returned for evaluation.The item and lot number have not been provided.X-rays or medical notes have not been provided.A historical search could not be performed as the item and lot number have not been provided.This device(s) is used for treatment.Not enough information has been provided to determine if all implants are compatible.A dhr review or a review of recalls could not be performed as the item and lot number have not been provided.The likely condition of the device(s) when it/they left zimmer biomet could not be determined as the item and lot number has not been provided.The root cause of the reported event can not be determined with the information provided.No corrective action is required at this time as the root cause of the reported event has not been determined.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
UNKNOWN OXF TIBIAL
Type of Device
UNKNOWN OXF
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK   CF31 3XA
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key13887363
MDR Text Key287806935
Report Number3002806535-2022-00179
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/24/2022
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 NumberUNKNOWN OXF TIBIAL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/08/2021
Initial Date FDA Received03/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
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