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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 MM INTERNAL ORTHOPAEDIC FIXATION SYSTEM

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ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 MM INTERNAL ORTHOPAEDIC FIXATION SYSTEM Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Patient Device Interaction Problem (4001)
Patient Problem Failure of Implant (1924)
Event Date 09/02/2021
Event Type  Injury  
Manufacturer Narrative
This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states. Concomitant medical products:: medical product: ncb, screw, 5. 0, 42 mm; item# 0203150042; lot# unknown; ncb, screw, 5. 0, 44 mm; item# 0203150044; lot# unknown; ncb, screw,¸ 5. 0, 50 mm; item# 0203150050; lot# unknown; ncb, screw, self-tapping, 4. 0 mm, 38 mm; item# 0203155038; lot# unknown; ncb, screw, self-tapping, 4. 0 mm, 40 mm; item# 0203155040; lot# unknown; ncb, screw, self-tapping,¸ 4. 0 mm, 42 mm; item# 0203155042; lot# unknown; ncb, locking cap; item# 0203150300; lot# unknown; unknown; item# 2232-001-18; lot# unknown. The manufacturer received x-rays for review. Other documents were received and will be reviewed as part of ongoing investigation. As no lot numbers were provided 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 the left side and underwent revision due to implant fracture.
 
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Brand NameNCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 15 HOLES, 324 MM
Type of DeviceINTERNAL ORTHOPAEDIC FIXATION 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 Key12546474
MDR Text Key273779231
Report Number0009613350-2021-00505
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodePL
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 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number02.03263.115
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/30/2021
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 Treatment Data
Date Received: 09/29/2021 Patient Sequence Number: 1
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