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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES; UNCEMENTED HIP ACETABULAR SHELL
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MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES; UNCEMENTED HIP ACETABULAR SHELL Back to Search Results
Catalog Number 01.32.154DH
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/26/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 7 august 2019: lot 185967: 71 items manufactured and released on 07-dec-2018.Expiration date: 2023-11-25.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.
 
Event or Problem Description
The patient came in, 5 months after primary surgery, complaining of instability which was due to a malpositioned cup.The surgeon revised the cup, liner and head.The surgery was completed successfully.
 
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Brand Name
CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
Common Device Name
UNCEMENTED HIP ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8925185
Report Number3005180920-2019-00707
Device Sequence Number253501
Product Code LPH
UDI-Device Identifier07630030810824
UDI-Public07630030810824
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K132879
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/23/2019
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 Date11/25/2023
Device Catalogue Number01.32.154DH
Device Lot Number185967
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/26/2019
Initial Report FDA Received Date08/23/2019
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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