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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H COATED LAT STEM SIZE 4; UNCEMENTED HIP STEM
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MEDACTA INTERNATIONAL SA AMISTEM H COATED LAT STEM SIZE 4; UNCEMENTED HIP STEM Back to Search Results
Model Number 01.18.144
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 09/23/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2021: lot 133083: 80 items manufactured and released on 09-oct-2013.Expiration date: 2018-aug-31.No anomalies found related to the problem.To date, 74 items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
The patient came in reporting pain due to a potted stem and the cause of the potted stem is unknown.7 years after the primary surgery, the surgeon revised the stem and head with competitor products and revised the medacta liner with a medacta liner.The surgery was completed successfully.
 
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Brand Name
AMISTEM H COATED LAT STEM SIZE 4
Common Device Name
UNCEMENTED HIP STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12687958
Report Number3005180920-2021-00823
Device Sequence Number4165851
Product Code LZO
UDI-Device Identifier07630030804205
UDI-Public07630030804205
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K093944
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/25/2021
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 Date08/31/2018
Device Model Number01.18.144
Device Catalogue Number01.18.144
Device Lot Number133083
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/26/2021
Initial Report FDA Received Date10/25/2021
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;
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