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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE L +4
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MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE L +4 Back to Search Results
Model Number 01.29.206
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/17/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 june 2021: lot 186541: (b)(4) items manufactured and released on 22-nov-2018.Expiration date: 2023-11-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
 
Event or Problem Description
Revision surgery 2 days after primary because post op, after agent inventory, it was recognized that the patient was implanted with a head 32 in a liner 36.The scrub tech, sales agent and surgeon did not notice that during the surgery.Head revised successfully.
 
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Brand Name
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE L +4
Common Device Name
CERAMIC BALL HEAD
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key12121055
Report Number3005180920-2021-00572
Device Sequence Number4429029
Product Code LZO
UDI-Device Identifier07630030809170
UDI-Public07630030809170
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K112115
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
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) 07/06/2021
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 Date11/13/2023
Device Model Number01.29.206
Device Catalogue Number01.29.206
Device Lot Number186541
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/17/2021
Initial Report FDA Received Date07/06/2021
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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