• 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 NCBA, FEMUR PLATE, RIGHT, 13 HOLES, 324 MM PLATE, FIXATION

  • 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 NCBA, FEMUR PLATE, RIGHT, 13 HOLES, 324 MM PLATE, FIXATION Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 03/05/2022
Event Type  Injury  
Event Description
It was reported that the patient underwent a right implant revision approximately 6 months post-op due to an implant fracture. No further information is available.
 
Manufacturer Narrative
(b)(4). Concomitant medical products: div. Schrauben: item# unknown; lot# unknown. Klemmschrauben: item# unknown; lot# unknown. Cerclagen: item# unknown; lot# unknown. Report source: foreign - germany. Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNCBA, FEMUR PLATE, RIGHT, 13 HOLES, 324 MM
Type of DevicePLATE, FIXATION
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 Key14692535
MDR Text Key294663241
Report Number0009613350-2022-00335
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00889024297388
UDI-Public(01)00889024297388(11)130521(10)2710830
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K042695
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number02.03260.013
Device Lot Number2710830
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/15/2022 Patient Sequence Number: 1
-
-