MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GREATER TROCHANTER FEMORAL NAIL - GREEN LEFT; TRAUMA IMPLANT

Model Number	47-2492-321-10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that initial surgery was performed with gtf nail on left side.Subsequently, the patient was revised due to pain from fall and fracture of the implant.Attempts have been made and no further information has been provided.
Event or Problem Description
No additional event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10 reported event was confirmed by review of radiographs.X-ray review noted the implant is fractured.The overall fit and alignment of the implants are appropriate on the postoperative film.The bone quality is normal.Cortical thickening of the lateral cortex of the proximal femoral diaphysis.Associated linear lucency in this region indicating possible early incomplete fracture.This anatomic area of weakness could have caused the implant to fracture.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: GREATER TROCHANTER FEMORAL NAIL - GREEN LEFT
• Common Device Name: TRAUMA IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9902681
• Report Number: 0001822565-2020-01074
• Device Sequence Number: 19005294
• Product Code: HSB
• UDI-Device Identifier: 00889024095878
• UDI-Public: (01)00889024095878(17)260731(10)63395571
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 47-2492-321-10
• Device Catalogue Number: 47249232110
• Device Lot Number: 63395571
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 52