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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SEG DIST FEM SIZE B RT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. SEG DIST FEM SIZE B RT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Damage to Ligament(s) (1952); No Information (3190)
Event Date 02/25/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical devices: stem extension straight 12mm dia x 100mm length (combined length 145mm) item#: 00598801012, lot# 64080937. Polyethylene insert xt size b use with distal femoral xt size b use with xt only item#: 00585001296, lot#: 64036066. Segment with male/female taper 30 mm length, item#: 00585004603, lot#: 64036552. Fluted stem extension straight precoat 14 mm diameter 130 mm length item#: 00585205014, lot#: 63793365. Tibial component precoat size 5 item#: 00588000500, lot#: 63753875. All poly patella standard size 38 mm diameter 9. 5 mm thickness cemented item#: 00597206538, lot#: 63289114. Stem collar 35 mm o. D. For use with 16 mm or smaller diameter segmental stems item#: 00585204035, lot#: 63720636. Articular surface with segmental hinge post size b 12 mm height item#: 00585002012, lot#: 63953180. Report source- (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation at this time as the device is still currently implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient is scheduled for a revision due to implant fracture. There is no additional information available at this time.
 
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Brand NameSEG DIST FEM SIZE B RT
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 Key9746036
MDR Text Key188403280
Report Number0001822565-2020-00668
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K150028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00585004202
Device Lot Number64073213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2018
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: 02/24/2020 Patient Sequence Number: 1
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