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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 36 SIZE XL
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MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE XL Back to Search Results
Model Number 01.29.211
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/23/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 3 july 2020: lot 142147a: (b)(4) items manufactured and released on 8-nov-2019.Expiration date: 2024-10-26.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 since 2016.
 
Event or Problem Description
The patient came in 21 days after the primary surgery due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the head.The surgery was completed successfully.
 
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Brand Name
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE XL
Common Device Name
CERAMIC BALL HEAD
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874, CHE
SZ  6874, CHE
MDR Report Key10301339
Report Number3005180920-2020-00436
Device Sequence Number16272363
Product Code LZO
UDI-Device Identifier07630030809224
UDI-Public07630030809224
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K112115
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/21/2020
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 No Information
Device Expiration Date10/26/2024
Device Model Number01.29.211
Device Catalogue Number01.29.211
Device Lot Number142147A
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/23/2020
Initial Report FDA Received Date07/21/2020
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;
Patient Age73 YR
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