• 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, RIGHT, 18 HOLES, 355 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, RIGHT, 18 HOLES, 355 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Insufficient Information (4580)
Event Date 09/03/2021
Event Type  Injury  
Manufacturer Narrative
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.As no not numbers were received the device history records couldn't be reviewed.The process of gaining necessary information is still ongoing.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 and underwent revision due to implant fracture.
 
Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.D10: medical products: ncb, screw, 5.0, 22 mm; catalog#: 02.03150.022; lot#: unknown.Ncb, screw, 5.0, 36 mm; catalog#: 02.03150.036; lot#: unknown.Ncb, screw, 5.0, 38 mm; catalog#: 02.03150.038; lot#: unknown.Ncb, screw, 5.0, 42 mm; catalog#: 02.03150.042; lot#: unknown.Ncb, screw, 5.0, 46 mm; catalog#: 02.03150.046; lot#: unknown.Ncb, screw, 5.0, 50 mm; catalog#: 02.03150.050; lot#: unknown.Ncb, screw, 5.0, 75 mm; catalog#: 02.03150.075; lot#: unknown.Ncb, cancellous screw, 5.0 mm, 32 mm, 70 mm; catalog#: 02.03152.070; lot#: unknown.Ncb, cancellous screw, 5.0 mm, 32 mm, 75 mm; catalog#: 02.03152.075; lot#: unknown.Unicortical screw 5.0 mm diameter 14 mm length warning: this device is not approved for screw attachment or fixation; catalog#: 02.03151.014; lot#: unknown.Therapy date: sep 3, 2021.Additional information was received on oct 11, 2021.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
 
Event Description
Patient was implanted on an unknown side and underwent a revision surgery due to implant fracture.
 
Manufacturer Narrative
Investigation results were made available.1.Event description: it was reported that the patient came to the hospital with a broken plate approximately 4 months after surgery.Harm: s3 - bone malunion/non-union, resulting in revision or other interventions hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.Review of received data: - due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.- x-rays: radiographs were provided and reviewed by a health care professional.Review of the available records identified an incompletely healed comminuted fracture of the distal femur with some bony callus formation.Visualized portion of the plate appears to be intact.- images: review of the received image identified that the plate fractured into two pieces through a screw hole.No other damage is noted; however, the device is covered in blood.- surgical report: the surgical report from 25 may 2021 has been reviewed, however no conspicuous findings relevant to the reported event have been identified.3.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: - document review could not be performed due to unknown product identification.- device purpose: this device is intended for treatment.- product compatibility: the product combination was approved by zimmer biomet.5.Conclusion: it was reported that the patient came to the hospital with a broken plate approximately 4 months after surgery.Based on the investigation the reported event can be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
 
Event Description
Investigation results are now available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NCB, PERIPROSTHETIC FEMUR PLATE, DISTAL, RIGHT, 18 HOLES, 355 MM
Type of Device
NCB 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 Key12524997
MDR Text Key273084553
Report Number0009613350-2021-00492
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00889024297586
UDI-Public00889024297586
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K100111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 12/09/2021
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? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number02.03264.018
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/07/2021
Initial Date FDA Received09/24/2021
Supplement Dates Manufacturer Received10/11/2021
11/26/2021
Supplement Dates FDA Received10/28/2021
12/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Sequence Number1
Treatment
SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
Patient Weight80 KG
-
-