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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT SIZE2; CEMENTLESS FEMORAL STEM
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MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT SIZE2; CEMENTLESS FEMORAL STEM Back to Search Results
Catalog Number 01.12.032
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Inadequate Osseointegration (2646); Insufficient Information (4580)
Event Date 07/29/2021
Event Type  Injury  
Event Description
Revision surgery was performed on (b)(6) 2021 due to the loosening of a quadra-h stem, 2 years and 6 months after the primary surgery.The ref and lot number are not available at this moment.
 
Manufacturer Narrative
Batch review performed on (b)(6) 2021: lot 178383: (b)(4) items manufactured and released on 20-mar-2018.Expiration date: 2023-03-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event.
 
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Brand Name
STEM: QUADRA-H CEMENTLESS, HA COATED LAT SIZE2
Type of Device
CEMENTLESS FEMORAL STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12377539
MDR Text Key268474472
Report Number3005180920-2021-00684
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
K082792
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/28/2021
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 Expiration Date03/08/2023
Device Catalogue Number01.12.032
Device Lot Number178383
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/29/2021
Initial Date FDA Received08/27/2021
Supplement Dates Manufacturer Received07/29/2021
Supplement Dates FDA Received09/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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