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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 +8
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MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE XL +8 Back to Search Results
Model Number 01.29.211
Health Effect - Clinical Codes Discomfort (2330); Unequal Limb Length (4534)
Date of Event 02/01/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12.Feb.2021: lot 183365: (b)(4) items manufactured and released on 7-aug-2018.Expiration date: 2023-07-29.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 discomfort 7 months after the primary surgery due to a leg length discrepancy.It was determined that the right leg was longer than the left leg.The surgeon revised the 36mm biolox delta head xl with a 36mm biolox delta head m.The surgery was completed successfully.
 
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Brand Name
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE XL +8
Common Device Name
CERAMIC BALL HEAD
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key11397760
Report Number3005180920-2021-00153
Device Sequence Number11904189
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 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) 03/02/2021
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 Date07/29/2023
Device Model Number01.29.211
Device Catalogue Number01.29.211
Device Lot Number183365
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/31/2021
Initial Report FDA Received Date03/02/2021
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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