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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 3 PMA; PROSTHESIS, KNEE

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BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 3 PMA; PROSTHESIS, KNEE Back to Search Results
Catalog Number 159568
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Joint Dislocation (2374)
Event Date 10/09/2023
Event Type  Injury  
Manufacturer Narrative
(b)(4).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that the patient underwent revision surgery due to dislocation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
 
Event Description
It was reported that the patient underwent revision surgery due to dislocation of the bearing and pain.
 
Manufacturer Narrative
(b)(4).D10.Item#:unknown ;lot#: unknown ;item name: unknown femoral component ; item#:unknown ;lot#: unknown ;item name: unknown tibial component; this follow-up report is being submitted to relay additional information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified that the spherical surface has some wear, dents and marks but is otherwise in good condition.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.The review identified initial right partial knee replacement was performed, and subsequently the patient was revised two years and four months later due to anterior dislocation of the poly.During the revision components were found to have clean surfaces without defect, the poly was revised without complications.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 ANAT BRG RT SM SIZE 3 PMA
Type of Device
PROSTHESIS, KNEE
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 Key18073034
MDR Text Key327397743
Report Number3002806535-2023-00373
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279786145
UDI-Public(01)05019279786145(17)260402(10)410100
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,Followup
Report Date 01/09/2024
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? Yes
Device Operator Lay User/Patient
Device Catalogue Number159568
Device Lot Number410100
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/09/2023
Initial Date FDA Received11/06/2023
Supplement Dates Manufacturer Received11/17/2023
01/05/2024
Supplement Dates FDA Received12/13/2023
01/09/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2021
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
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Required Intervention; Hospitalization;
Patient SexFemale
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