MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE FEM COMP COCR CEM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported in a register report from (b)(6) that there were four revision surgeries performed to replace the insert implant genesis ii dished and the genesis ii ldk cocr femoral component due to unspecified reasons.There is no additional information about the hospital, patient, and surgery data.The eprd provided this information as part of a cumulative statistical study regarding failure frequency.This report states that there have been 17 revision surgeries, however we received on 17-feb-2021 a previous report with 13 revision surgeries which were covered under (b)(4) fda report number: 1020279-2021-02103 / bfarm reference: (b)(4).Based on this information, we report the remaining 4 revision surgeries in the present complaint.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no relevant supporting clinical information could be provided to assist with this clinical investigation, as the data was reported in a register report from eprd (endoprothesenregister deutschland) that there were four revision surgeries performed to replace the insert implant and the femoral component due to unspecified reasons.There is no additional information about the hospital, patient, and surgery data.The eprd provided this information as part of a cumulative statistical study regarding failure frequency.Per case details, no further information is available.Therefore, based on insufficient information, further clinical root cause analysis cannot be performed.The current condition of each patient is unknown and the patient impact beyond the reported events could not be determined.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.Some potential probable causes for this event could include but not limited to procedural/user error, surgical complication or patient medical history.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.Internal complaint reference number: (b)(4).

• Brand Name: UNKN GENESIS II TOTAL KNEE FEM COMP COCR CEM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-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: 14674654
• MDR Text Key: 293838326
• Report Number: 1020279-2022-02908
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention