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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA DM HC LINER ACETABULAR DOUBLE MOBILITY LINER

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MEDACTA INTERNATIONAL SA DM HC LINER ACETABULAR DOUBLE MOBILITY LINER Back to Search Results
Catalog Number 01.26.2852MHC
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2018
Event Type  malfunction  
Manufacturer Narrative
Batch review performed on 25 june 2018; lot 177529: (b)(4) items manufactured and released on 14 march 2018. Expiration date:2023-02-28; 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. Preliminary investigation performed by packaging deparment manager on june 28 2018: "the impurity detected is very low, not easy detectable, and could maybe be considered as acceptable related to the acceptability criteria. Examples: - a 2 mm impurity (hair like, etc. ) can be accepted if not concerning the internal part of the blister, more than 2 mm can not be acceptable. - a metal sliver inside the blister can't be accepted. No more considerations can be done on the photos provided.
 
Event Description
When the implant was opened it was noticed that there was a hair-like substance inside the inner most packaging. The implant was wasted and a secondary was opened to complete the surgery. The surgery was completed successfully.
 
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Brand NameDM HC LINER
Type of DeviceACETABULAR DOUBLE MOBILITY LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ 6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key7645617
MDR Text Key112872513
Report Number3005180920-2018-00471
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092265
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 06/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number01.26.2852MHC
Device Lot Number177529
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/30/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/28/2018 Patient Sequence Number: 1
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