MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN GENESIS KNEE IMPL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKN01200100

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 01/01/1901

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a tka-ps construct had been implanted, several patients experienced the breakage of the knee insert post.A revision surgery was necessary to remove the broken insert, although the identity of the prosthesis implanted in exchange for each patient is unknown at this time.No further information is available.

Manufacturer Narrative

Section h3, h6: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the screw of the hk-motion insert began backing out approximately 17 months post implantation.Reportedly, the patient is ¿very per complaint details, several patients experienced the breakage of the knee insert post.The requested patient-specific medical documentation has not been received as of the date of this medical investigation.The current health status of each patient remains unknown.Without the requested clinical documentation, the root cause of the reported events could not be further assessed.The patients¿ impact beyond the reported insert post breakages and revisions could not be determined.No further medical assessment could be rendered at this time.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury, abnormal loadings on the implant or surgical technique.The contribution of the devices 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 products involved, our investigation could not proceed.Should the devices 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.

• Brand Name: UNKN GENESIS KNEE IMPL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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 Key: 14462707
• MDR Text Key: 292356179
• Report Number: 1020279-2022-02479
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

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 Number: UNKN01200100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 06/17/2022
• Supplement Dates FDA Received: 06/20/2022
• 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 Number: 1
• Patient Outcome(s): Required Intervention