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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 10 MM, 21.5 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

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ZIMMER GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 10 MM, 21.5 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348)
Event Date 09/07/2016
Event Type  Injury  
Manufacturer Narrative
The manufacturer did not receive devices, x-rays, or other source documents for review. 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. Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted. (b)(4).
 
Event Description
It was reported that the patient was implanted a cmn femoral nail, ccd 130, right, 10 mm, 21. 5 cm on (b)(6) 2016. The patient was revised on (b)(6) 2016 due to breakage and pain.
 
Manufacturer Narrative
Trend analysis: no trend identified. Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended. - event summary: it was reported by the patient (mail received) that a znn nail was implanted on (b)(6) 2016 and revised on (b)(6) 2016 due to a nail breakage. The nail breakage occurred in august. Review of received data - no x-rays have been sent to winterthur for evaluation. - the medical documentation of the patient was received for investigation. The surgical report of implantation and explantation and other patient related documents were available. Surgical report of implantation dated (b)(6) 2016: diagnosis: subtrochanteric fracture right femur suspected to be pathologic. Procedure: a znn nailing system was implanted to treat the fracture. No abnormality could be found on the surgical steps performed by the surgeon. Surgical report of explantation dated (b)(6) 2016. Diagnosis: nonunion of the right femur subtrochanteric fracture with a broken proximal im nail. Procedure: the surgeon had some difficulties to remove the lag screw and also the distal screw (cortical screw). Afterwards, a new znn nail was implanted (long). In another patient document (history and physical) admission date (b)(6) 2016, it is stated that the patient had in the past vulva cancer for which she was treated surgically and she received radiation therapy. The surgeon assumes that the delayed bone healing (nonunion) can be possible related to the post radiation changes in her bone. There are two further discharge summaries (admission date (b)(6) 2015 and admission date (b)(6) 2016) available which describes groin pain and mobility issues which was not diagnosed for several months. Her pain got worse. The x-rays showed sub trochanteric fracture of the femur. The documents do also show that the patient had disc herniation, see exam date (b)(6) 2016. In addition we received the patient implant records (implant labels) for both surgeries and the visit times of the patient. Devices analysis no product was returned to zimmer biomet for in-depth analysis review of product documentation - the compatibility check was performed and showed that the product combination was approved by zimmer biomet. Conclusion summary the patient, female, (b)(6) had an intertrochanteric fracture of the right femur. A znn nail was implanted on (b)(6) 2016. A revision was performed on (b)(6) 2016 due to a nail breakage. The devices have not been returned to zimmer biomet winterthur for investigation. Several patient documents were received. The nail was in vivo for approx. 9 months. The nail breakage was occurred in (b)(6) 2016. The surgical report of explantation describes that the nail was broken due to non union. The normal bone healing process did not occur. It is also mentioned that the patient had in the past vulva cancer for which she was treated surgically and she received radiation therapy. The surgeon assumes that the delayed bone healing can be possible related to the post radiation changes in her bone. However, an exact root cause for the nail breakage after approx. 9 months could not be determined. The need for further corrective measures is not indicated and zimmer (b)(4) considers this case as closed. (b)(4).
 
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Brand NameCMN FEMORAL NAIL, CCD 130, RIGHT, 10 MM, 21.5 CM
Type of DeviceZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
kevin escapule
1800 west center street
warsaw, IN 46580
8006136131
MDR Report Key6180635
MDR Text Key62546207
Report Number0009613350-2016-01450
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
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 11/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2493-212-10
Device Lot Number2805281
Other Device ID Number00889024298910
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2016 Patient Sequence Number: 1
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