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

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN DISTAL PART, CURVED, UNCEMENTED, 18/140

  • 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
 

ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN DISTAL PART, CURVED, UNCEMENTED, 18/140 Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Material Integrity Problem (2978)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Impaired Healing (2378)
Event Date 03/03/2020
Event Type  Injury  
Manufacturer Narrative
Medical product: revitan, proximal part, cylindrical, uncemented, 75, taper 12/14; item#0100402075; lot#2857924; the manufacturer did not receive x-rays for review. Other source documents were received and will be reviewed as part of ongoing investigation. As no lot number was provided, the device history records could not be reviewed. Additional information has been requested and is currently not available. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet's reference number of this file is (b)(4).
 
Event Description
Patient was implanted on an unknown side in 2017. Post the surgery there was no proper bone healing around the revitan shaft which resulted in fracture at the coupling between revitan distal and proximal part.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREVITAN DISTAL PART, CURVED, UNCEMENTED, 18/140
Type of DeviceREVITAN DISTAL PART, CURVED, UNCEMENTED, 18/140
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9864684
MDR Text Key194483184
Report Number0009613350-2020-00144
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Model NumberN/A
Device Catalogue Number01.00406.118
Device Lot Number2784549
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/23/2020 Patient Sequence Number: 1
-
-