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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 56 CEMENTLESS ACETABULAR SHELL

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MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 56 CEMENTLESS ACETABULAR SHELL Back to Search Results
Catalog Number 01.26.56MB
Device Problem Fracture (1260)
Patient Problem Bone Fracture(s) (1870)
Event Date 05/17/2017
Event Type  Injury  
Manufacturer Narrative
Additional information received on (b)(6) 2017 and includes: the patient had some type of syndrome that caused the anatomy to not be normal. On (b)(6) 2017 the medical affairs director performed a clinical evaluation and commented as follows: intraoperative acetabular fractures are known possible adverse events of total hip replacements, described and quantified in literature. They mainly depend on bone morphology and mechanical properties. In this case, according to the report, the acteabular component was well fixed and didn't require any additional procedure. There is no reason to suspect a malfunctioning device. Batch review performed on (b)(6) 2017. Lot 161584: 69 items manufactured and released on (b)(6) 2016. Expiration date: 2021-06-02. No anomalies found related to the problem. To date, 46 items of the same lot have been already sold without any similar reported event. The cup was left in place, not explanted.
 
Event Description
After impaction of the cup, the surgeon noticed the acetabular wall had fractured. The cup was well fixed. No additional implants needed, no revision is required. The surgery was completed successfully.
 
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Brand NameVERSAFITCUP ACETABULAR SHELL Ø 56
Type of DeviceCEMENTLESS ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, 6874
SZ   6874
MDR Report Key6646021
MDR Text Key77704179
Report Number3005180920-2017-00315
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 06/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/02/2021
Device Catalogue Number01.26.56MB
Device Lot Number161584
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/14/2016
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: 06/16/2017 Patient Sequence Number: 1
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