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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM SM PMA; KNEE PROSTHESIS

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BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM SM PMA; KNEE PROSTHESIS Back to Search Results
Catalog Number 161468
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 01/29/2024
Event Type  Injury  
Manufacturer Narrative
(b)(4).D10 - associated medical devices: oxf uni tib tray sz b rm pma; item# 154721; lot# 592820.Oxf anat brg rt sm size 3 pma; item# 159568; lot# 218830.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00071.3002806535-2024-00073.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that the patient underwent a revision surgery approximately seven years post initial implantation due to unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.
 
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00071-1.3002806535-2024-00073-1.This follow-up report is being submitted to relay additional and/or corrected information.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
OXF TWIN-PEG CMNTD FEM SM PMA
Type of Device
KNEE PROSTHESIS
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 Key18776189
MDR Text Key336183072
Report Number3002806535-2024-00072
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/27/2024
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 Lay User/Patient
Device Catalogue Number161468
Device Lot Number332200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/29/2024
Initial Date FDA Received02/26/2024
Supplement Dates Manufacturer Received03/21/2024
Supplement Dates FDA Received03/27/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/08/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient SexPrefer Not To Disclose
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