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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TIBIAL COMPONENT SIZE 3 CEMENTED PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. UNKNOWN TIBIAL COMPONENT SIZE 3 CEMENTED PROSTHESIS, KNEE Back to Search Results
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Date 11/15/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical product: unknown femoral component size 3 cemented: catalog#ni, lot#ni; unknown articular surface 11mm: catalog#ni, lot#ni; unknown 8mm patella: catalog#ni, lot#ni; unknown cement: catalog#ni, lot#ni. Multiple mdr reports have been filed for this event. Please see associated reports: 0001822565-2022-00649; 0001822565-2022-00650. Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product location is unknown. 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 underwent an initial left total knee arthroplasty. The patient was doing well until nine months post op when a car rolled over his left foot and twisted his left knee. The patient developed significant pain in his knee and underwent an arthroscopic debridement of post-traumatic scar tissue approximately 13 months post implantation. The surgery alleviated the pain and diminished range of motion for a while. One year later, the pain and range of motion issues returned with flexion instability. The patient was then revised two years post initial implantation. During the revision, it was noted that the tibia was in about 10-15° of internal rotation compared to the medial 1/3 of the tubercle. The articular surface and tibial and femoral components were exchanged without complication. Attempts have been made and no further information has been provided at the time of this report.
 
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Brand NameUNKNOWN TIBIAL COMPONENT SIZE 3 CEMENTED
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 Key13666194
MDR Text Key286563989
Report Number0001822565-2022-00651
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173057
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/16/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/04/2022 Patient Sequence Number: 1
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