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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F LEFT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F LEFT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Unstable (1667)
Patient Problems Pain (1994); Swelling (2091); Synovitis (2094); Reaction (2414)
Event Date 05/24/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: articular surface with hinge post extension screw enclosed do not discard size f 12 mm height. Tibial component precoat size catalog 00588000500 lot 62057301. All poly patella size 32 mm dia. Standard 8. 5 mm thickness catalog 00597206532 lot 62034479. Customer has indicated that the product will not be returned to zimmer biomet for investigation. 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: 0001822565-2019-02444, 0001822565-2019-02445, 0001822565-2019-02446.
 
Event Description
It was reported that the patient underwent a revision procedure approximately seven years post implantation due to swelling, pain, elevated levels of co and cr in his blood after which the knee was judged as unstable. During the revision thick gray/ black fluid was noted; the surgeon noted that hypermobility may have caused stress on the hinge possibly contributing to the patient's high cobalt chromium levels. The articular surface, hinge pin, and tibial bushing were removed and replaced.
 
Event Description
Additional information received.
 
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Brand NameFEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F LEFT
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8692647
MDR Text Key147775753
Report Number0001822565-2019-02445
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K013385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2017
Device Model NumberN/A
Device Catalogue Number00588001601
Device Lot Number61871353
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/12/2019 Patient Sequence Number: 1
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