• 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 FIXED BEARING 10 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 FIXED BEARING 10 MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Unstable (1667)
Patient Problems Damage to Ligament(s) (1952); Pain (1994); Swelling (2091); No Code Available (3191)
Event Date 01/14/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Udi # (b)(4). Concomitant medical products: 2. 5 mm female hex screw 25 mm length, catalog #: 42509902525, lot #: 63767187, headed screw 48 mm length, catalog #: 00579104100, lot #: 63767203, headed screw 48 mm length, catalog #: 00579104100, lot #: 63698701, tibia cemented 5 degree stemmed left size f, catalog #: 42532007501, lot #: 63683016, stem extension tapered cemented 14 mm diameter +30 mm length, catalog #: 42557000114, lot #: 63793414, femur cemented posterior stabilized (ps) standard left size 9, catalog #: 42500606601, lot #: 63742681, all-poly patella cemented 35 mm diameter, catalog #: 42540200035, lot #: 63604776.

 
Event Description

It was reported that a patient underwent left tka. Subsequently, the patient was revised approximately two years post-implantation due to instability.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARTICULAR SURFACE FIXED BEARING 10 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 Key9616896
MDR Text Key175900234
Report Number3007963827-2020-00027
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42512400710
Device LOT Number63674976
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 Received03/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/22/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 01/22/2020 Patient Sequence Number: 1
Treatment
.
-
-