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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZA RM; OXFORD PARTIAL KNEE SYSTEM

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BIOMET UK LTD. OXF UNI TIB TRAY SZA RM; OXFORD PARTIAL KNEE SYSTEM Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 08/30/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).This is a combined initial / final report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.Medical product: oxf anat brg rt sm size 3 pma, catalog #: 159568, lot #: 2493985.Medical product: oxf twin-peg cmntd fem sm pma, catalog #: 161468, lot #: 902210.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00383, 3002806535-2021-00384.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.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 2 complaints reported with the item 159568, 13 complaints reported with the item 161468 and 2 complaints reported with the item 154719 (including initiating complaint).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 right knee arthroplasty on (b)(6) 2015.Subsequently, a revision procedure due to unknown reason was performed (b)(6) 2021.Attempts have been made but no further information has been provided.
 
Event Description
It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2015.Subsequently, a revision procedure due to unknown reason was performed aug 30, 2021.Attempts have been made but no further information has been provided.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: 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.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 2 complaints reported with the item 159568 and 154719 and 13 complaints reported with the item 161468 (including the initiating complaint).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.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00383-1; 3002806535-2021-00384-1.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : the product has been discarded.
 
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Brand Name
OXF UNI TIB TRAY SZA RM
Type of Device
OXFORD PARTIAL KNEE SYSTEM
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key12446050
MDR Text Key270521003
Report Number3002806535-2021-00385
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279388851
UDI-Public05019279388851
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,health
Type of Report Initial,Followup
Report Date 09/17/2021
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 Number154719
Device Lot Number720470
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/30/2021
Initial Date FDA Received09/09/2021
Supplement Dates Manufacturer Received08/30/2021
Supplement Dates FDA Received09/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
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