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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-H PROX. COAT. AMISTEM-H PROXIMAL COATING STD STEM SIZE 3
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MEDACTA INTERNATIONAL SA STEM: AMISTEM-H PROX. COAT. AMISTEM-H PROXIMAL COATING STD STEM SIZE 3 Back to Search Results
Catalog Number 01.18.173
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 12/11/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 december 2019.Lot 177119: (b)(4) items manufactured and released on 12-feb-2018.Expiration date: 2023-02-01.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.
 
Event or Problem Description
The patient came in complaining of pain due to a potted stem.The surgeon revised the stem and head 1 year and 7 months after primary.The surgery was completed successfully.
 
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Brand Name
STEM: AMISTEM-H PROX. COAT. AMISTEM-H PROXIMAL COATING STD STEM SIZE 3
Common Device Name
PROXIMAL COATING STD STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key9563215
Report Number3005180920-2019-01126
Device Sequence Number3229734
Product Code LZO
UDI-Device Identifier07630030804380
UDI-Public07630030804380
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 Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/08/2020
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 Date02/01/2023
Device Catalogue Number01.18.173
Device Lot Number177119
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/11/2019
Initial Report FDA Received Date01/08/2020
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;
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