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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK; HIP CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK; HIP CEMENTLESS STEM Back to Search Results
Model Number 01.12.22SN
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 02/19/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 february 2021: lot 170194: (b)(4) items manufactured and released on 16-june-2017.Expiration date: 2022-06-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
 
Event or Problem Description
The patient came in reporting pain.Post-op x-rays revealed that the stem potted distally.The surgeon revised the stem and head and added a sleeve 3 years 2 months after the primary.
 
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Brand Name
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2, SHORT NECK
Common Device Name
HIP CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11493346
Report Number3005180920-2021-00219
Device Sequence Number5349247
Product Code JDI
UDI-Device Identifier07630030802621
UDI-Public07630030802621
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K082792
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/16/2021
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 Date06/01/2022
Device Model Number01.12.22SN
Device Catalogue Number01.12.22SN
Device Lot Number170194
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/19/2021
Initial Report FDA Received Date03/16/2021
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;
Patient Age67 YR
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