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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POLYETHYLENE INSERT XT SIZE B USE WITH DISTAL FEMORAL XT SIZE B USE WITH XT ONLY PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. POLYETHYLENE INSERT XT SIZE B USE WITH DISTAL FEMORAL XT SIZE B USE WITH XT ONLY PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Hematoma (1884); Joint Dislocation (2374)
Event Date 04/21/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: 00585002014 64510506 articular surface with segmental hinge post; 00599003420 63553256 femoral augment; 00598801112 63542117 stem extension straight; 00598802017 63082997 stem extension offset. Foreign country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03263.
 
Event Description
It was reported the patient underwent an initial right total knee arthroplasty. Subsequently, the patient was revised approximately 2 years post implantation through a 2 stage revision to a rotating hinge knee. Approximately 6 days post revision, it was reported the patient¿s leg failed and he slipped off the bed when he got up in his room on the ward. The patient hypereflexed his right knee while sutures were still in situ from the previous revision. He had an open reduction of a joint dislocation with lavage and reconstruction of the capsular ligament of the knee joint. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NamePOLYETHYLENE INSERT XT SIZE B USE WITH DISTAL FEMORAL XT SIZE B USE WITH XT ONLY
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 Key10550765
MDR Text Key207512707
Report Number0001822565-2020-03262
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00585001296
Device Lot Number64510164
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 Received01/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/17/2020 Patient Sequence Number: 1
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