MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CUSTOM RS FEMORAL AXLE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product - 9mm short cps anchor plug catalog# cp561286 lot# 375920, 16cm rs lt screw exp catalog# cp114882 lot# 367190, 47x14x70mm avl tibia catalog# cp114885 lot# 367070, cps transverse pin 6pk 20mm catalog# 178524 lot# 332470, 30mm 400lb shrt cps spdl catalog# cp114881 lot# 366980, custom avl tibial bushing set catalog# cp111207 lot# 536990, cps nut co-cr-mo alloy catalog# 178512 lot# 964120, oss poly lock pin catalog# 150478 lot# 695070, custom avl lock ring set of 2 catalog# cp111215 lot# 537020, cust rs avl tib brng set catalog# cp114883 lot# 537050, cust rs avl yoke set catalog# cp114884 lot# 537030, cust rs fem bshg set catalog# cp114887 lot# 573140.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 that patient had an initial left arthroplasty on unknown date.Subsequently, the surgeon is requesting a distal femur expandable implant to tibia for a planned revision due to unknown reasons.

• Brand Name: CUSTOM RS FEMORAL AXLE
• Type of Device: PROSTHESIS, KNEE
• 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: 7371364
• MDR Text Key: 103516510
• Report Number: 0001825034-2018-02211
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PCUSTOM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CP114886
• Device Lot Number: 573110
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2014
• 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): Hospitalization; Required Intervention