MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 34 CM

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product.Znn, cmn lag screw, 10.5 mm, 105 mm including set screw catalog no#: 47248404050 ; lot#: 2905527.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head catalog no#: 47248404050 ; lot#: 63351068.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head catalog no#: 47248404550 ; lot#: 63579469.Therapy date: (b)(6) 2018.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received, 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.(b)(4).
Event or Problem Description
Patient was implanted on the right side and underwent revision surgery due to intertrochanteric malunion.
Event or Problem Description
Please refer to report 0009613350-2018-01223.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend considering the following event is identified: fracture malunion.Event description: it was reported that a right zimmer natural nail system was implanted in a 76-year old female patient on (b)(6) 2018 and revised on (b)(6) 2018 due to intertrochanteric malunion.The nail was removed and a total hip arthroplasty was performed.Review of received data: - one undated x-ray of bad quality was received.The following x-ray review was performed by a health care professional.Right hip ap-view: situation after osteosynthesis of an intertrochanteric fracture of the right femur with a natural nail system.No evidence of bony healing, dehiscence of fragments, fracture margins sclerosed.At the nail entry point in the area of the distal fragment, medially and laterally, a radiolucent line is visible at the interface between nail and surrounding bone.The lag screw is too steep in the upper third of the femoral neck.- the operation report of the implantation was received for review: (b)(6) hospital.Surgeons: (b)(6).Anaesthetists: (b)(6).Date of operation:(b)(6) 2018.Operation details: closed reduction of fracture of femur with internal fixation.Intramedullary nail, right femur.Procedure: incision over greater trochanter for femoral nail.Guidewire checked with ii.Femoral canal reamed progressively.Insertion of nail - ii check.Lag screw inserted to femoral head.Good position on ii.Subcapital neck of femur fracture not displaced.2 x distal screws distally under ii guidance.- otherwise, no medical documentation is available such as the explantation report, office notes, intraoperative images, images of the retrievals, patient anamnesis or patient adherence to rehabilitation protocol.Device analysis: the hospital did not agree to return the product to zimmer biomet for in-depth analysis.Review of product documentation: the product combination was approved by zimmer biomet.Conclusion: it was reported that a right zimmer natural nail system was implanted in a 76-year old female patient on (b)(6) 2018 and revised on (b)(6) 2018 due to intertrochanteric malunion.The nail was removed after 9 months in-vivo and revised to a total hip arthroplasty.The device was not returned for investigation.The x-ray review showed that the mentioned malunion is clearly visible on the received x-ray, also showing a dehiscence of the fragments and a steep positioning of the lag screw into the upper third of the femoral neck.Based on the received surgical report it stays unknown whether the surgical technique was followed or not.The quality records show that all specified characteristics of the zimmer natural nail (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Therefore, based on the reported event and the x-ray review, the most likely root cause for this revision is an intertrochanteric malunion in combination with a steep positioning of the lag screw in the upper third of the femoral neck, therefore, this revision is considered as not device-related.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: CMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 34 CM
• Common Device Name: CMN FEMORAL NAIL
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8159516
• Report Number: 0009613350-2018-01223
• Device Sequence Number: 16716165
• Product Code: HSB
• UDI-Device Identifier: 00889024299504
• UDI-Public: 00889024299504
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-342-11
• Device Lot Number: 2863669
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention