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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNK FEMORAL BIOMET OXFORD CEMENTED; KNEE PROSTHESIS

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BIOMET UK LTD. UNK FEMORAL BIOMET OXFORD CEMENTED; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Biocompatibility (2886); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Patient Problems 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 - medical devices: unk bearing biomet oxford left medial anatomic, 6mm; item# unknown; lot# unknown unk tibia biomet oxford medial cementless sz.D; item# unknown; lot# unknown h3 - product was discarded multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00354 3002806535 - 2023 - 00355 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.H3 other text : product is unknown.
 
Event Description
It was reported that the patient had undergone a left unicompartmental knee arthroplasty.Subsequently, the patient experienced dislocation of the bearing and had a recurrent episode of dislocation.Approximately four years later, the patient underwent revision surgery due to pain and recurrent dislocations.During the procedure, significant synovitis with a metallosis appearance and scarring on the anterior flange were encountered.Initially, the surgeon had planned a poly swap, but this resulted in a conversion to a total knee arthroplasty.While trialing the bearing, the femoral component popped off due to a lack of ingrowth.All components, except for the tibial component, were revised without complications.Due diligence is in progress for this complaint; to date no additional information or product has been received.
 
Manufacturer Narrative
(b)(4).Upon reassessment of the reported event, it was determined a medwatch report should not have been filed under the current manufacturer as the complaint is a duplicate of (b)(4)- mdr report number 3002806535-2023-00352.Given this information, this medwatch will be voided.
 
Event Description
Upon reassessment of the reported event, it was determined a medwatch report should not have been filed under the current manufacturer as the complaint is a duplicate of (b)(4) - mdr report number 3002806535-2023-00352.Given this information, this medwatch will be voided.
 
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Brand Name
UNK FEMORAL BIOMET OXFORD CEMENTED
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 Key17994019
MDR Text Key326350278
Report Number3002806535-2023-00355
Device Sequence Number1
Product Code NRA
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 11/03/2023
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 Model NumberN/A
Device Catalogue NumberUNKNOWN FEMORAL COMPNONENT
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/29/2023
Initial Date FDA Received10/24/2023
Supplement Dates Manufacturer Received10/25/2023
Supplement Dates FDA Received11/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 SexMale
Patient Weight105 KG
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