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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE FEM COMP; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

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SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE FEM COMP; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER Back to Search Results
Catalog Number UNKN01200103
Device Problem Loss of Osseointegration (2408)
Patient Problem Inadequate Osseointegration (2646)
Event Date 04/28/2021
Event Type  Injury  
Event Description
It was reported that on literature review "long-term outcomes and duration of outdoor ambulation following primary total knee arthroplasty in patients with rheumatoid arthritis ", 1 patient had mechanical loosening of the femoral component after a tka procedure using genesis ii implants 2.3 years later.The event was treated by revision surgery.Patient outcome is unknown.No further information is available.
 
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, definitive contributing clinical factors could not be concluded.The patient impact beyond the mechanical loosening of the non-cemented femoral component reported in the literature article with revision to a cemented component approximately 2.3 years post implantation could not be determined.Per the article, however, ¿no patients had mechanical loosening after femoral component fixation was changed from cementless to cemented¿¿.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal motion over time, bone degeneration, loss of ingrowth, osteolysis and/or traumatic injury.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
 
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Brand Name
UNKN GENESIS II TOTAL KNEE FEM COMP
Type of Device
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key15546858
MDR Text Key301235253
Report Number1020279-2022-04339
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/11/2022
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 Catalogue NumberUNKN01200103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/16/2022
Initial Date FDA Received10/05/2022
Supplement Dates Manufacturer Received11/09/2022
Supplement Dates FDA Received11/11/2022
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 A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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