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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET SPAIN, S.L. POLISHED FINNED TIB TRAY 63MM; PROSTHESIS, KNEE
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BIOMET SPAIN, S.L. POLISHED FINNED TIB TRAY 63MM; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Pain (1994)
Event Date 03/11/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Associated products: tibial bearing ref 189022, lot 082450; cr femoral ref.183022, lot j3813089; cement ref.4720502083-1, lot a727b05290.This product is manufactured by biomet (b)(4) orthopaedics, s.L.And is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states under 510(k) number k945028.Device not returned yet.
 
Event Description
It has been reported that on (b)(6) 2019 the patient underwent a primary knee prosthesis with vanguard.The patient started with constant pain which became disabling.The surgeon decided to review the total prosthesis.During the revision surgery on (b)(6) 2021, a total detachment of the vanguard tibial plate was detected, without any cement residue at the base.
 
Event Description
It has been reported that on (b)(6) 2019 the patient underwent a primary knee prosthesis with vanguard.The patient started with constant pain which became disabling.The surgeon decided to review the total prosthesis.During the revision surgery on (b)(6) 2021, a total detachment of the vanguard tibial plate was detected, without any cement residue at the base.
 
Manufacturer Narrative
(b)(4).D10.Associated products: tibial bearing ref (b)(4), lot 082450; cr femoral ref (b)(4), lot j3813089; cement ref (b)(4), lot a727b05290.G5: this product is manufactured by biomet spain orthopaedics, s.L.And is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet warsaw manufactures a similar device that is cleared or distributed in the united states under 510(k) number k945028.
 
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Brand Name
POLISHED FINNED TIB TRAY 63MM
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET SPAIN, S.L.
calle islas baleares, #50
p.o. box 96
fuente del jarro, valencia 46988
SP  46988
MDR Report Key11549772
MDR Text Key241931337
Report Number0009610576-2021-00003
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 06/29/2021
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 Health Professional
Device Model NumberN/A
Device Catalogue Number141251
Device Lot Number2018080444
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/12/2021
Initial Date FDA Received03/23/2021
Supplement Dates Manufacturer Received03/12/2021
Supplement Dates FDA Received06/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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