MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS INTLK DIST STM TI BM/PC 15MMX250MM; PROTHESIS HIP

Model Number N/A

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Information (3190)

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

Customer has indicated that the product will not be returned to zimmer biomet for investigation.Visual inspection of the impactor shows the strike plate is fractured off the handle.The product shows obvious signs of wear and tear from being in use since 2015.The lip of the handle where the strike plate threads into is deformed, most likely from when the strike plate fractured off.Failure mode is consistent with excessive and off center strikes on the plate.Review of device history records found these units were released to distributor with no deviations or abnormalities.Root cause could not be determined.This device is used for treatment.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

T was reported that the patient underwent an initial left total hip arthroplasty on an unknown date in 2001 with competitor products.Subsequently, the patient was revised on (b)(6) 2016 due to periprosthetic fracture.During the procedure, the tip of a femoral stem had punctured the inner sterile packaging.The stem was used, as the outer packaging was not damaged and this was the only stem of this size that was available.

• Brand Name: ARCOS INTLK DIST STM TI BM/PC 15MMX250MM
• Type of Device: PROTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6908882
• MDR Text Key: 88159530
• Report Number: 0001825034-2017-07788
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: PNOT CLEARED
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 22-301915
• Device Lot Number: 208800
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1