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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MOD ARTHRO NL 1CM DIASL CNCTR PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. MOD ARTHRO NL 1CM DIASL CNCTR PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Joint Dislocation (2374); No Code Available (3191)
Event Date 07/09/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices - modular arthrodesis nail diaphyseal connector 1cm, catalog #: cp260605, lot #: 236860; modular arthrodesis nail diaphyseal connector 1cm, catalog #: cp260605, lot #: 161950; orthopedic salvage system intramedullary stem 21. 5mm x 150mm, catalog #: 150400, lot #: 360910; orthopedic salvage system intramedullary stem 18. 5mm x 225mm, catalog #: 150405, lot #: 898500; unknown orthopedic salvage system femoral component, catalog #: ni, lot #: ni; unknown orthopedic salvage system tibial component, catalog #: ni lot #: ni; unknown orthopedic salvage system tibial bushing, catalog #: ni, lot #: ni; unknown orthopedic salvage system femoral bushing, catalog #: ni lot #: ni, unknown orthopedic salvage system yoke catalog #: ni, lot #: ni; unknown orthopedic salvage system axle, catalog #: ni, lot #: ni; unknown orthopedic salvage system locking pin, catalog #: ni, lot #: ni. The product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It is reported that the patient underwent a left knee arthroplasty revision approximately one (1) year and six (6) months post-operatively to address implant fracture. No additional patient consequences were reported.
 
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Brand NameMOD ARTHRO NL 1CM DIASL CNCTR
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 Key8863752
MDR Text Key153365675
Report Number0001825034-2019-03444
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042409
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberCP260605
Device Lot Number236860
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2018
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: 08/06/2019 Patient Sequence Number: 1
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