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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN PEG CMNTLS FMRL MD; PROSTHESIS, KNEE

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BIOMET UK LTD. OXF TWIN PEG CMNTLS FMRL MD; PROSTHESIS, KNEE Back to Search Results
Catalog Number 161474
Device Problems Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Joint Dislocation (2374); Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Event Date 09/26/2023
Event Type  Injury  
Manufacturer Narrative
(b)(4).D10.Item#:159547 ;lot#:679030 ;item name: oxf anat brg lt md size 3 pma; multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00353.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 due to pain and instability.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 due to pain, loosening, dislocation and metallosis.
 
Manufacturer Narrative
(b)(4).D10: item#:159547 ;lot#:371130 ;item name: oxf anat brg lt md size 3 pma; visual examination of the returned product identified nicks, gouges and wear on the surface of the bearing component.The femoral component appears to have some scratches to the bearing surface and some bone ongrowth to the porous surface.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.Medical records were provided and reviewed by a health care professional.The review identified aseptic loosening.Hemorrhage observed with what appeared to be some metallos in addition to a significant amount of scar on the anterior flange.When the knee was flexed to remove the bearing, the bearing was levered up and the femur "popped off.".No evidence of bony ingrowth on the back of the femur with posterior condyle showing no evidence of lytic areas and with bone intact without defects.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
OXF TWIN PEG CMNTLS FMRL MD
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 Key17985181
MDR Text Key326300438
Report Number3002806535-2023-00352
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279442270
UDI-Public(01)05019279442270(17)251113(10)R2503466A
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
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 11/17/2023
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? Yes
Device Operator Lay User/Patient
Device Catalogue Number161474
Device Lot NumberR2503466A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/26/2023
Initial Date FDA Received10/23/2023
Supplement Dates Manufacturer Received10/25/2023
Supplement Dates FDA Received11/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2015
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) Required Intervention; Hospitalization;
Patient SexMale
Patient Weight105 KG
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