MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN FEMORAL NAIL, CCD 125°, LEFT, 10 MM, 21.5 CM; ROD, FIXATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 04/08/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that a femoral nail was implanted to treat a femoral neck fracture and that the patient experienced persistent pain in the hip area, even though the bone had healed.The device was found to be fractured and a revision surgery took place, approximately 1.5 year after implantation.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Product was not returned for investigation.Lot identification is necessary for review of device history records, lot identification was not provided.Device is used for treatment medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZNN, CMN FEMORAL NAIL, CCD 125°, LEFT, 10 MM, 21.5 CM
• Type of Device: ROD, FIXATION
• 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 Key: 14673740
• MDR Text Key: 293826959
• Report Number: 0009613350-2022-00330
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47249321110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2022
• 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 Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization