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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD SIZE 3; FEMORAL CEMNTED STEM
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MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD SIZE 3; FEMORAL CEMNTED STEM Back to Search Results
Model Number 01.18.153
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 02/03/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 march 2021: lot 182726: (b)(4) items manufactured and released on 10-july-2018.Expiration date: 2023-06-25.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 due to stem loosening 1 year 6 months after the primary.The cause of the stem loosening is unknown.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
STEM: AMISTEM C CEMENTED STD SIZE 3
Common Device Name
FEMORAL CEMNTED STEM
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11422145
Report Number3005180920-2021-00167
Device Sequence Number2776224
Product Code LZO
UDI-Device Identifier07630030804281
UDI-Public07630030804281
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K103189
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
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) 03/05/2021
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 Date06/25/2023
Device Model Number01.18.153
Device Catalogue Number01.18.153
Device Lot Number182726
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/03/2021
Initial Report FDA Received Date03/05/2021
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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