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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25; SHOULDER GLENOID BASEPLATE

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MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25; SHOULDER GLENOID BASEPLATE Back to Search Results
Catalog Number 04.01.0155
Device Problem Microbial Contamination of Device (2303)
Patient Problem Unspecified Infection (1930)
Event Date 05/15/2019
Event Type  Injury  
Manufacturer Narrative
Batch review performed on 17 october 2019: lot 175039: (b)(4) items manufactured and released on 07-mar-2018.Expiration date: 2023-02-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.Additional devices involved.Batch reviews performed on 17 october 2019: reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 174748: (b)(4) items manufactured and released on 30-jan-2018.Expiration date: 2023-01-16.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.Reverse shoulder system 04.01.0163 glenoid polyaxial locking screw - l38 (k170452) lot 174286: (b)(4) items manufactured and released on 12-oct-2017.Expiration date: 2022-10-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one other similar event reported.Reverse shoulder system 04.01.0174 glenosphere 42x27 (k170452) lot 163806: (b)(4) items manufactured and released on 20-dec-2016.Expiration date: 2021-11-08.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.Reverse shoulder system 04.01.0127 humeral reverse hc liner ø42/+6mm (k170452) lot 173411: 72 items manufactured and released on 21-jun-2017.Expiration date: 2022-05-31.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.Reverse shoulder system 04.01.0158 glenoid polyaxial locking screw - l18 (k170452) lot 182473: (b)(4) items manufactured and released on 04-sep-2018.Expiration date: 2023-08-22.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.Reverse shoulder system 04.01.0006 std humeral diaphysis - cementless - 11 (k170452) lot 178132: (b)(4) items manufactured and released on 29-mar-2018.Expiration date: 2023-03-08.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.Reverse shoulder system 04.01.0110 reverse methaphysis +0mm/0° (k170452) lot 174650: 152 items manufactured and released on 5-feb-2018.Expiration date: 2023-01-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with two other similar events reported.
 
Event Description
On (b)(6) the patient refluxated (the patient have a complex clinical history, he is spastic).On (b)(6) all the implants have been explanted due to infection.New implants have been implanted on (b)(6) 2019, 4 months after primary surgery.Revision surgery completed successfully.
 
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Brand Name
REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø27X25
Type of Device
SHOULDER GLENOID BASEPLATE
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 Key9254778
MDR Text Key174197407
Report Number3005180920-2019-00925
Device Sequence Number1
Product Code PHX
UDI-Device Identifier07630040706421
UDI-Public07630040706421
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K170452
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 10/30/2019
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
Device Operator Health Professional
Device Expiration Date02/26/2023
Device Catalogue Number04.01.0155
Device Lot Number175039
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/04/2019
Initial Date FDA Received10/30/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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