MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS SHORT ANCHOR PLUG 20MM PROSTHESIS, KNEE

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Noise, Audible (3273); Migration (4003)

Patient Problems Osteopenia/ Osteoporosis (2651); Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Associated products: item#: 178364; cps xs sht spdl w pins 800lbf; lot# 662280, item#: 178544; cps centering sleeve 22mm; lot# 903010, item#: 178526; cps transverse pin 6pk 28mm; lot# 965300. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03992, 0001825034-2020-00480, 0001825034-2020-00481.

Event Description

It is reported that the patient underwent a left knee arthroplasty revision to address tibial component loosening approximately two (2) months post-operatively. Initial operative notes reported that the patient had very thin tibial bone, which required additional cuts for implant placement. Revision operative notes reported that the implant was clearly loose at its bone interface and had collapsed down on the bone completely. The compress device was removed and placed again using five (5) cross pins and loading 600 pounds of compression. A centering sleeve and spindle were also placed to fit the tibia.

• Brand Name: CPS SHORT ANCHOR PLUG 20MM
• 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: 9667662
• MDR Text Key: 177795189
• Report Number: 0001825034-2020-00479
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 178562
• Device Lot Number: 608710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2017
• 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 Treatment Data

Date Received: 02/04/2020 Patient Sequence Number: 1