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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 STD STEM SIZE 5; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5; CEMENTLESS HIP STEM Back to Search Results
Model Number 01.12.025
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 02/06/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 february 2020.Lot 121506: (b)(4) items manufactured and released on 26-jun-2012.Expiration date: 2017-05-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2016.
 
Event or Problem Description
The patient returned to the hospital for review, pain in the hip.Stem loosening was detected therefore requiring revision surgery 6 years and 5 months after "prmary".The surgery was completed successfully.
 
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Brand Name
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9785489
Report Number3005180920-2020-00118
Device Sequence Number16787676
Product Code JDI
UDI-Device Identifier07630030802065
UDI-Public07630030802065
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K082792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Expiration Date05/31/2017
Device Model Number01.12.025
Device Catalogue Number01.12.025
Device Lot Number121506
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/03/2020
Initial Report FDA Received Date03/04/2020
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;
Patient Age68 YR
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