MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TROCHANTERIC NL XSH 13MMX17CM; ROD, FIXATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Pain (1994); Discomfort (2330); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: ti-dble lead cort 5.0x38mm scr, catalog 14-405038, lot 235990; osseotite solid fixed 115mm, catalog 30262, lot 687470.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that approximately six months post implantation the patient underwent revision of a trochanteric nail due to implant fracture.

Event Description

It was reported that approximately six months post implantation the patient underwent revision of a trochanteric nail due to implant fracture and delayed union.Prior to the revision procedure, it was reported the patient had experienced discomfort, limb length discrepancy, mild restrictions of internal and external rotation, and pain.It was further noted that the patient developed evidence of implant failure on the lateral corner of the implant adjacent to the lag screw.The implant failure led to a loss of alignment and varus angulation of the proximal femur.

Manufacturer Narrative

Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product confirmed the reported event as the nail is fractured in the lag screw hole.Scanning electron microscopy determined the fracture surface artifacts suggest the nail fractured from fatigue fractures with one fracture showing torsional fatigue characteristics.Material analysis confirmed the material is conforming.Dhr was reviewed and no discrepancies were found.Root cause could not be determined.A summary of the investigation has been sent to the complainant.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.

Event Description

No additional information received.

• Brand Name: TROCHANTERIC NL XSH 13MMX17CM
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8457941
• MDR Text Key: 140078489
• Report Number: 0001825034-2019-01444
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K050118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 28823
• Device Lot Number: 615640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 91