MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN LAG SCREW 10.5MM X 110MM; PROSTHESIS, TRAUMA

Catalog Number 814510110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02766.Concomitant medical devices: part# 281001100; lot# 311650; part# 281001175; lot# m6bad5a; part# 814311180; lot# 082740; part# 814550038; lot# m12600twa; part# 814501095; lot# uc1111295e.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.

Event Description

It was reported patient underwent an initial surgery on the right hip approximately nine (9) months ago.Approximately four (4) months postimplantation, patient was revised due to affixus nail cutting out of the femoral head.Surgeon stated patient had poor bone quality and the placement of the lag screw might not have been optimal.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to user error as these devices were implanted when poor bone quality is a contraindication for use (off-label usage).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.

Event Description

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

• Brand Name: HFN LAG SCREW 10.5MM X 110MM
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10284922
• MDR Text Key: 199984619
• Report Number: 0001825034-2020-02765
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 814510110
• Device Lot Number: TP1111310A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention