• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEAD Ø28X49 HIP BIPOLAR HEAD

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDACTA INTERNATIONAL SA BIPOLAR HEAD Ø28X49 HIP BIPOLAR HEAD Back to Search Results
Model Number 25060.2849
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 02/20/2022
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 23 feb 2022: lot 180449: 34 items manufactured and released on 13-jun-2018. Expiration date: 2023-may-28. No anomalies found related to the problem. To date, 25 items of the same lot have been sold with no similar reported event. Additional device involved: batch review performed on 23 feb 2022: ball heads: mectacer 01. 29. 202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot 2111102: 200 items manufactured and released on 24-noc-2021. Expiration date: 2026-nov-11 no anomalies found related to the problem. To date, 109 items of the same lot have been sold with no similar reported event.
 
Event Description
The patient came in due to signs of an infection and the pathogen is unknown. About 2 weeks after the primary surgery, the surgeon performed a washout and revised the head and the surgery was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIPOLAR HEAD Ø28X49
Type of DeviceHIP BIPOLAR HEAD
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, switzerland 6874
SZ   6874
MDR Report Key13802614
MDR Text Key287430026
Report Number3005180920-2022-00191
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091967
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number25060.2849
Device Catalogue Number25060.2849
Device Lot Number180449
Was Device Available for Evaluation? No
Date Manufacturer Received02/20/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/13/2018
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: 03/17/2022 Patient Sequence Number: 1
-
-