MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII NONPOROUS PS FEM SZ 6 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a multi fragmentary periprosthetic fracture of the right distal femur, the patient underwent a surgery on (b)(6) 2022, in which a reduction and an osteosynthesis with a plate (competitor's device), screws (competitor's device) and wad with bone grafts were performed.After this intervention, the patient presented loss of fracture reduction, dehiscence of the surgical wound, loosening of one screw, partial loosening of two other screws and signs of local septic inflammation.Therefore, the patient underwent a revision surgery on (b)(6) 2022 for the removal of synthesis and knee prosthesis including the gii nonporous ps fem sz 6 rt, the gii ps hi flex isrt sz 5 6 9 and the gns ii cmt tib size 5 right, in order to perform a resection of the distal femur and knee arthrodesis with cemented arthrodesizing nail.The patient current status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the root cause of the s+n tka ¿revision¿ was secondary to the reported loss of fracture reduction/loosened competitor synthesis media, post-operative wound dehiscence and local septic inflammation which were the contributing factors to the reported revision of the competitor synthesis media and s+n tka components, although patient age and unknown comorbidities could not be ruled out as potential contributing factors to the reported events.The documentation provided does not support a malperformance of the s+n tka prosthetic components.The patient impact beyond the reported post-operative complications and subsequent ¿revision¿/resection/arthrodesis could not be determined.No further medical assessment could be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture or to support that the probable cause was related to a malperformance of the s+n device.A probable cause to the reported event could include but not limited to patient condition, traumatic injury and/or post operative healing issues 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: case (b)(4).

• Brand Name: GII NONPOROUS PS FEM SZ 6 RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 14638378
• Report Number: 1020279-2022-02810
• Device Sequence Number: 17572865
• Product Code: JWH
• UDI-Device Identifier: 03596010206053
• UDI-Public: 03596010206053
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2020
• Device Model Number: 71420122
• Device Catalogue Number: 71420122
• Device Lot Number: 10AM08153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GII PS HI FLEX ISRT SZ 5-6 9, LOT#:10FT43233; GNS II CMT TIB SIZE 5 RIGHT, LOT#:09LT37068
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown