• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 12 MM PROSTHESIS, KNEE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 12 MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 01/07/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: 42502806002, femur, lot # 64278763, 42530006702, tibia, lot # 64102955, 00587806535, patella, lot # 6425270. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 00526, 0001822565 - 2020 - 00527.

 
Event Description

It was reported that approximately 2 months post implantation, the patient was experiencing stiffness and consequently underwent a manipulation under anesthesia with injection of the right knee. Approximately 2 weeks post manipulation, the patient's swelling had reportedly resolved. Attempts have been made and no further information has been provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 12 MM
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer (Section G)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9681151
MDR Text Key178121626
Report Number3007963827-2020-00043
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150090
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 03/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42522100412
Device LOT Number63811402
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 Received03/12/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/26/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/07/2020 Patient Sequence Number: 1
-
-