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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA; OXFORD HXLPE BEARINGS

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BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA; OXFORD HXLPE BEARINGS Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 10/18/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical products: customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.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 an initial knee arthroplasty on (b)(6) 2011.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021.
 
Event Description
It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2011.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021.Attempts have been made but no further information has been provided at this time.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Product has not been returned for evaluation.X-rays or medical notes have not been provided.The investigation has been limited to the information provided, a review of the device history records, and a complaint history search.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of complaint history was assessed for three years prior to the notification date and identified (1) similar complaints for item #159576 (including initiating complaint).There were (0) additional complaints against the lot #2115075.This device is used for treatment.Not enough information has been provided to determine if all implants are compatible.These part and lot combinations are not associated with any recalls at the time the search was conducted.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can not be determined with the information provided no corrective action required at this time as the root cause of the reported event has not been determined.These part and lot combinations are not associated with any recalls as of current date.
 
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Brand Name
OXF ANAT BRG RT MD SIZE 4 PMA
Type of Device
OXFORD HXLPE BEARINGS
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 Key12671286
MDR Text Key277626181
Report Number3002806535-2021-00458
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279786220
UDI-Public05019279786220
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/20/2022
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 Number159576
Device Lot Number2115075
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/19/2021
Initial Date FDA Received10/21/2021
Supplement Dates Manufacturer Received01/19/2022
Supplement Dates FDA Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age71 YR
Patient SexMale
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