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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 4 PMA; KNEE PROSTHESIS

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BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 4 PMA; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
Event Date 07/27/2023
Event Type  Injury  
Manufacturer Narrative
(b)(4).D10: medical product: oxf twin-peg cmntd fem sm pma; catalog no.: 161468; lot no.: 767490.Medical product: oxf uni tib tray sz aa rm pma; catalog no.: 159532; lot no.: 485700.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00272, 3002806535-2023-00274.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 patient underwent knee prostheses implantation approximately six (6) years ago.About six (6) years later patient complained of knee pain, resulting in revision surgery with exchanging knee prostheses.Attempts have been made and no further information has been provided.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00272-1, 3002806535-2023-00274-1.This follow-up report is being submitted to relay additional and/or corrected information.No product was 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.Devices are used for treatment.Radiographs were provided and reviewed by a radiologist.Medial unicompartmental arthroplasty is present.There is radiolucency along the tibial and to a lesser degree femoral implants consistent with osteolysis.There is no implant displacement.There is suspected loosening of the tibial implant but no prior imaging is available for comparison to confirm this.Bone quality is osteopenic.With the available information, a definitive root cause cannot 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.
 
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Brand Name
OXF ANAT BRG RT SM SIZE 4 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 Key17562680
MDR Text Key321309338
Report Number3002806535-2023-00275
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279786152
UDI-Public(01)05019279786152(17)220713(10)006730
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 08/17/2023
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 Expiration Date07/13/2022
Device Model NumberN/A
Device Catalogue Number159569
Device Lot Number006730
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/27/2023
Initial Date FDA Received08/17/2023
Supplement Dates Manufacturer Received10/06/2023
Supplement Dates FDA Received10/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2017
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 SexFemale
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