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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 2; CEMENTLESS HIP STEM
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MEDACTA INTERNATIONAL SA AMISTEM-H PROXIMAL COATING STD STEM SIZE 2; CEMENTLESS HIP STEM Back to Search Results
Catalog Number 01.18.172
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/21/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 october 2018: lot 180053: (b)(4) items manufactured and released on 17 may 2018.Expiration date: 2023-05-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
Revision surgery, 17 days after primary, due to stem subsidence.The surgeon removed the stem and head and implanted another company's product.
 
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Brand Name
AMISTEM-H PROXIMAL COATING STD STEM SIZE 2
Common Device Name
CEMENTLESS HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7984653
Report Number3005180920-2018-00812
Device Sequence Number148683
Product Code LZO
UDI-Device Identifier07630030804373
UDI-Public07630030804373
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K161635
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/19/2018
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 Date05/08/2023
Device Catalogue Number01.18.172
Device Lot Number180053
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/21/2018
Initial Report FDA Received Date10/19/2018
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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