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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE TIB INSERT; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
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SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE TIB INSERT; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER Back to Search Results
Catalog Number UNKNOWN
Device Problems Defective Component (2292); Compatibility Problem (2960)
Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Event Date 05/20/2020
Event Type  Injury  
Event Description
It was reported that during surgery, right after removing the original insert, the surgeon implanted a patella and thoroughly cleaned and cleared the tibial base plate and surrounding tissue to insert the replacement poly.After 3 failed attempts to lock down the poly a second back up poly was opened and impacted down correctly on the first attempt.It is unknown if there was any delay nor injury reported.
 
Manufacturer Narrative
It was reported that during surgery, right after removing the original insert, the surgeon implanted a patella and thoroughly cleaned and cleared the tibial base plate and surrounding tissue to insert the replacement poly.After 3 failed attempts to lock down the poly a second back up poly was opened and impacted down correctly on the first attempt.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.Possible causes could include but are not limited to size of device or surgical technique used.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
 
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Brand Name
UNKN GENESIS II TOTAL KNEE TIB INSERT
Type of Device
PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10166213
MDR Text Key195524845
Report Number1020279-2020-02481
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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