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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. CPS SHORT ANCHOR PLUG 20MM PROSTHESIS, KNEE Back to Search Results
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.
 
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Brand NameCPS SHORT ANCHOR PLUG 20MM
Type of DevicePROSTHESIS, 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 Key9667662
MDR Text Key177795189
Report Number0001825034-2020-00479
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062998
Number of Events Reported1
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 Received02/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number178562
Device Lot Number608710
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 Received02/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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