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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P STD STEM SIZE 6; CEMENTLESS STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM P STD STEM SIZE 6; CEMENTLESS STEM Back to Search Results
Catalog Number 01.18.406
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 10/11/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 october 2019.Lot 1810242: 70 items manufactured and released on 22-mar-2019.Expiration date: 2024-03-13.No anomalies found related to the problem.To date, 39 items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
Revision surgery performed 4 months after the primary due to instability due to a slightly subsided stem.The surgeon revised the 28 mm cocr head m with a 28 mm cocr head xxl and revised the versafitcup dm liner hc 58/28 with a versafitcup dm liner hc 58/28.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM P STD STEM SIZE 6
Common Device Name
CEMENTLESS STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9283658
Report Number3005180920-2019-00945
Device Sequence Number16181892
Product Code LZO
UDI-Device Identifier07630040720052
UDI-Public07630040720052
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K173794
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/06/2019
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 Date03/13/2024
Device Catalogue Number01.18.406
Device Lot Number1810242
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/11/2019
Initial Report FDA Received Date11/06/2019
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 Age83 YR
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