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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-P QUADRA-P LAT STEM SIZE 4; CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: QUADRA-P QUADRA-P LAT STEM SIZE 4; CEMENTLESS STEM Back to Search Results
Catalog Number 01.12.144
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Pain (1994)
Date of Event 08/02/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2021.Lot 1909275: 25 items manufactured and released on 11-05-2020.Expiration date: 2025-04-21.No anomalies found related to the problem.To date, 14 items of the same lot have been sold without a similar reported event.
 
Event or Problem Description
2 months after the primary surgery the patient came in reporting pain due to a subsided stem and the cause of the subsided stem is unknown.The surgeon revised the stem and head and the surgery was completed successfully.
 
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Brand Name
STEM: QUADRA-P QUADRA-P LAT STEM SIZE 4
Common Device Name
CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12405942
Report Number3005180920-2021-00682
Device Sequence Number17468976
Product Code LZO
UDI-Device Identifier07630040720564
UDI-Public07630040720564
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K181254
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/01/2021
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
Operator of Device Health Professional
Device Expiration Date04/21/2025
Device Catalogue Number01.12.144
Device Lot Number1909275
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/02/2021
Initial Report FDA Received Date09/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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