MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII DISHED INS SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/

Model Number	71420778
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: case-(b)(4).
Event or Problem Description
It was reported in a register report from (b)(6) that there were nine revision surgeries performed to replace the insert implant genesis ii dished ins size 5-6 9mm.There is no additional information about the hospital, patient and surgery data.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H6: the affected complaint devices, used in treatment, were not returned for evaluation.Therefore, a product analysis could not be performed.There is no information that would suggest the device failed to meet specifications.A review of complaint history revealed no prior complaints for the listed part.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.The potential probable causes for this event could include but not limited to a user or procedural error.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the probable cause failures were documented appropriately.The potential probable causes for this event could include but not limited to a patient condition, user or procedural error.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.
Additional Manufacturer Narrative
The affected complaint devices, used in treatment, were not returned for evaluation and the reported events could not be confirmed.The clinical/medical investigation concluded that smith and nephew has not received patient specific documentation, the explanted device, and/or adequate materials to fully evaluate the root cause of the complaint.Patient impact beyond that which was reported (insert revision) could not be determined.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Without sufficiently relevant information about alleged faults or malfunctions, no probable causes can be delineated at this time.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.

• Brand Name: GII DISHED INS SZ 5-6 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11479178
• Report Number: 1020279-2021-02109
• Device Sequence Number: 3276204
• Product Code: JWH
• UDI-Device Identifier: 03596010209382
• UDI-Public: 03596010209382
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71420778
• Device Catalogue Number: 71420778
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 07/28/2021; 09/24/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 07/28/2021; 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention