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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB BRG LG SZ4; KNEE PROTHESIS
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BIOMET UK LTD. OXFORD UNI TIB BRG LG SZ4; KNEE PROTHESIS Back to Search Results
Model Number N/A
Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial report.Concomitant medical products: item name : oxford uni femoral lg, item : 154602, lot : 1178517.Item name : oxf uni tib tray sz d lm pma, item : 154724, lot : 1167846.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00067-1, 3002806535-2020-00239.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Devices remain implanted.
 
Event Description
It was reported the patient underwent a left partial knee arthroplasty in 2004.Subsequently, the patient claims to be suffering from loss of range of motion, instability, hyperextension, pain and has to use a cane to walk.The revision is scheduled for (b)(6) 2020, but of that may change due to the current situation with covid 19.Product information received (b)(6) 2020.
 
Event Description
It was reported the patient underwent a left partial knee arthroplasty in 2004.Subsequently, the patient claims to be suffering from loss of range of motion, instability, hyperextension, pain and has to use a cane to walk.************************************************************************************************** the revision is scheduled for may 13, 2020, but of that may change due to the current situation with covid 19.
 
Manufacturer Narrative
(b)(4) this final report is being submitted to relay additional information.The following sections were updated: a4, b4, b5, e1, e2, e3, g4, g7, h1, h2, h6, h10.D11: medical product: oxf uni tib tray sz d lm pma, catalog #: 154724, lot #: 1167846 medical product: oxford uni femoral lg, catalog #: 154602, lot #: 1178517 medical product: cobalt hv bone cement 40gm b, catalog #: 402432, lot #: 12312006 multiple mdr reports were filed for this event, please see associated reports:3002806535-2020-00239-1, 3002806535-2020-00067-2.The product has not been returned to biomet for evaluation, therefore, a thorough investigation has not been possible.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of manufacturing history record shows no abnormalities or deviations.A review of complaint history search has found: -1 similar complaint with item 154602 -3 similar complaint with item 154724 -no similar complaint with 154635 without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Additional information: revision surgery took place on (b)(6) 2020.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00067-3, 3002806535-2020-00239-2.Follow-ups sent requesting further information, whether the product is available for return.If any further information is found which would change or alter any conclusions or information (or product is received), a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Product return requested.
 
Event Description
It was reported the patient underwent a left partial knee arthroplasty in 2004.Subsequently, the patient claims to be suffering from loss of range of motion, instability, hyperextension, pain and has to use a cane to walk.The revision is scheduled for (b)(6) 2020, but of that may change due to the current situation with covid 19.Information received stating that the revision surgery took place on (b)(6) 2020.
 
Event Description
It was reported the patient underwent a left partial knee arthroplasty in 2004.Subsequently, the patient claims to be suffering from loss of range of motion, instability, hyperextension, pain and has to use a cane to walk.The revision is scheduled for (b)(6) 2020, but of that may change due to the current situation with covid-19.Information received stating that the revision surgery took place on (b)(6) 2020.
 
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00067-4, 3002806535-2020-00239-3.Additional information: risk assessment updated: the event reports patient claim of oxford knee failure.Risk management report documents the estimated residual risk associated with the device within the reported event.The root cause of the issue however could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.At the time of conducting this risk assessment, the items remain implanted.However, the reported event states loss of range of motion.This has a maximum severity score of 4 defined in the rmp as results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention.Therefore, the reported event is in line with the risk file.The reported event also states instability.This has a maximum severity score of 4 defined in the rmp as results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention.Therefore, the reported event is in line with the risk file.The reported event also states pain.This has a maximum severity score of 4 defined in the rmp as results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention.Therefore, the reported event is in line with the risk file.The outcome of this complaint is therefore considered to be within the severity of the rmr.If further information regarding the root cause of the reported event are provided risk should be re-assessed.
 
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Brand Name
OXFORD UNI TIB BRG LG SZ4
Type of Device
KNEE PROTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key10016771
MDR Text Key191690173
Report Number3002806535-2020-00240
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279388400
UDI-Public05019279388400
Combination Product (y/n)N
PMA/PMN Number
PO1004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2011
Device Model NumberN/A
Device Catalogue Number154635
Device Lot Number1154626
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight136
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