• 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 NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 15 HOLES, 317 MM NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

  • 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 NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 15 HOLES, 317 MM NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Material Integrity Problem (2978)
Patient Problems Fall (1848); Non-union Bone Fracture (2369)
Event Date 08/02/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: ncb, cable button for ncb polyaxial locking plate, 2. 5 mm hex drive; catalog#: 47-2232-060-01; lot#: 3052253; ncb, cable button for ncb polyaxial locking plate, 2. 5 mm hex drive; catalog#: 47-2232-060-01; lot#: 3038385; ncb, cortical screw, 5. 0 mm, 34 mm; catalog#: 02. 02150. 034; lot#: 3055201; ncb, cortical screw, 5. 0 mm, 50 mm; catalog#: 02. 02150. 050; lot#: 3042101; ncb, cortical screw, 5. 0 mm, 60 mm; catalog#: 02. 02150. 060; lot#: 3052032; ncb, cortical screw, 5. 0 mm, 65 mm; catalog#: 02. 02150. 065; lot#: 3051305; ncb, cortical screw, 5. 0 mm, 65 mm; catalog#: 02. 02150. 065; lot#: 3036585; ncb, cortical screw, 5. 0 mm, 65 mm; catalog#: 02. 02150. 065; lot#: 2973779; ncb, cortical screw, 5. 0 mm, 75 mm; catalog#: 02. 02150. 075; lot#: 2961109; ncb, cortical screw, 5. 0 mm, 80 mm; catalog#: 02. 02150. 080; lot#: 3056483; ncb, locking cap; catalog#: 02. 02150. 300; lot#: 3054453; ncb, cortical screw, 5. 0 mm, 42 mm; catalog#: 02. 02150. 042; lot#: 2974504; ncb, locking cap; catalog#: 02. 02150. 300; lot#: 3054280; ncb, cable button for ncb polyaxial locking plate, 2. 5 mm hex drive; catalog#: 47-2232-060-01; lot#: 3035075; ncb, cable button for ncb polyaxial locking plate, 2. 5 mm hex drive; catalog#: 47-2232-060-01; lot#: 3035079; ncb, locking cap; catalog#: 02. 02150. 300; lot#: 3035978; ncb, locking cap; catalog#: 02. 02150. 300; lot#: 3035975; cable-ready cable grip system; catalog#: 2232-04-18; lot#: 64793092; cable-ready cable grip system; catalog#: 2232-04-18; lot#: 64840101; cable-ready cable grip system; catalog#: 2232-04-18; lot#: 64793651; cable-ready cable grip system; catalog#: 2232-04-18; lot#: 64957404. Therapy date: (b)(6) 2021. The manufacturer received x-rays for review. Other documents were received and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. 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 biomets reference number of this file is (b)(4).
 
Event Description
Patient was implanted on the left side and underwent a revision surgery due to plate fatigue. The patient fell onto her right side while closing the curtains. X-rays revealed abundance of callus formation, non union of previous fracture and fatigue failure of the plate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, LEFT, 15 HOLES, 317 MM
Type of DeviceNCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
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 Key12330273
MDR Text Key266839284
Report Number0009613350-2021-00409
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K100111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number02.02264.115
Device Lot Number2952347
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/15/2018
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: 08/17/2021 Patient Sequence Number: 1
-
-