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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MOD ARTHRO 0 DEG LCK COLLAR PLATE, FIXATION

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ZIMMER BIOMET, INC. MOD ARTHRO 0 DEG LCK COLLAR PLATE, FIXATION Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 04/13/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-02183, 0001825034-2019-02185, and 0001825034-2019-02186. Udi: (b)(4). Concomitant medical products: mod arthro nl 3cm diasl cnctr, catalog#: cp260607, lot#: ni. Oss segmental stacking adapter, catalog# 150483, lot#: 302180. Unknown screw, catalog#: ni, lot#: ni. Cps lg spdl with pins 800lbf, catalog#: 178358, lot#: 502600. Cps lg spdl with pins 800lbf, catalog#: 178404, lot#: 213070. Cps transverse pin 6pk 32mm, catalog#: 178527, lot#: 134880. Cps centering sleeve 18mm, catalog#: 178540, lot#: 131070. Cps nut co-cr-mo alloy, catalog#: 178512, lot#: 498690. Cps anchor plug 10mm, catalog#: 178400, lot#: 182490. Cps sm spdl with pins 800lbf, catalog#: 178355, lot#: 717020. Cps/oss 5cm tpr adapt w/oss sc, catalog#: 178711, lot#: 433100. Cps nut co-cr-mo alloy, catalog#: 178512, lot#: 222820. Cps transverse pin 6pk 32mm, catalog#: 178527, lot#: 742300. Cps centering sleeve 15mm, catalog#: 178537, lot#: 935290. Cps/oss 5cm tpr adapt w/oss sc, catalog#: 178711, lot#: 250750. Mod arthro nl 3cm diasl cnctr, catalog#: cp260607, lot#: 580090. Oss 4cm diaphyseal segment, catalog#: 150482, lot#: 801580. Oss segmental stacking adapter, catalog#: 150483, lot#: 580530. Mod arthro 0 deg lck collar, catalog#: cp260600, lot#: 491090. Mod arthro nl 3cm diasl cnctr, catalog#: cp260607, lot#: 181570. 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 was reported that patient underwent initial knee arthroplasty. Subsequently, underwent a revision due the implant fractured while walking four (4) year five (5) months post primary implantation. Patient was walking five mile per day.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameMOD ARTHRO 0 DEG LCK COLLAR
Type of DevicePLATE, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8612566
MDR Text Key145133868
Report Number0001825034-2019-02184
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K042049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberCP260600
Device Lot Number341290
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2019
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/15/2019 Patient Sequence Number: 1
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