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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN FEMORAL COMPONENT; PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. UNKNOWN FEMORAL COMPONENT; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Pain (1994); Synovitis (2094); Burning Sensation (2146); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: unknown - unknown tibial component - unknown; unknown - unknown articular surface - unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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: 0001822565-2023-00377 and 0001822565-2023-00378.
 
Event Description
It was reported that a patient underwent an initial knee arthroplasty.Subsequently, the patient has been complaining of swelling, instability, and pain.They also note the knee is hot to the touch and the leg below the kneecap is bellying out.The patient has seen multiple physicians and has had x-rays taken.With physical testing, they doctors have noticed there is loosening.Attempts have been made and no further information has been provided.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: suggested component code: mechanical (g04) - femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: boggy effusion or synovitis, evolving periprosthetic lucency surrounding the tibial stem, consistent with loosening, potential crack within the tibial cement, cortical defect/osteolysis noted in the medial femoral condyle, potential subsidence of the tibial stem.The complaint was confirmed.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent an initial left total knee arthroplasty due to a work-related injury resulting in bilateral knee posttraumatic arthritis.Since the initial procedure, the patient has complained of ongoing and increasing pain, swelling, instability, limp, and heat in the joint.The patient has been recommended for revision surgery as recent x-rays suggest loosening.Attempts have been made and no further information has been provided.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 3007963827-2023-00356.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
UNKNOWN FEMORAL COMPONENT
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer (Section G)
ZIMMER BIOMET, INC.
1800 w. center st.
warsaw IN 46580
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key16381339
MDR Text Key309604528
Report Number0001822565-2023-00376
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 12/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/27/2023
Initial Date FDA Received02/15/2023
Supplement Dates Manufacturer Received03/14/2023
04/13/2023
12/12/2023
Supplement Dates FDA Received04/04/2023
04/13/2023
12/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
Patient Weight101 KG
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