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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS, LLC TAPERLOC COMPLETE PRIMARY FEMORAL; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
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BIOMET ORTHOPEDICS, LLC TAPERLOC COMPLETE PRIMARY FEMORAL; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL Back to Search Results
Catalog Number 51-103140
Device Problem Material Fragmentation (1261)
Patient Problem Insufficient Information (4580)
Event Date 07/17/2021
Event Type  malfunction  
Event Description
During the surgical procedure (hip revision) the surgeon explanted the femoral stem from the patient.After the stem was explanted, the surgeon noticed an area of the porous coating was chipped from the stem.The stem reference #51-103140, lot 6743500.The surgeon requested the zimmer sales representative take the explant back to the manufacturer.The explant was removed from the sterile field as is and double bagged and given to the sales representative.
 
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Brand Name
TAPERLOC COMPLETE PRIMARY FEMORAL
Type of Device
PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
Manufacturer (Section D)
BIOMET ORTHOPEDICS, LLC
56 east bell dr. p.o. box 587
warsaw IN 46581
MDR Report Key12300498
MDR Text Key265794980
Report Number12300498
Device Sequence Number1
Product Code KWL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number51-103140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/26/2021
Event Location Hospital
Date Report to Manufacturer08/10/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age21535 DA
Patient Weight82
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