MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 35MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Model Number	71420578
Medical Device Problem Codes	No Apparent Adverse Event (3189); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2017, the patient experienced severe pain on the lateral side of his knee.X-rays showed malposition of the patella and patella tracking.Intra operatively, the patient had a significant hemarthrosis, the patella button was loose and the physician estimated that the tibial component was placed about 8mm of internal rotation.This adverse event was solved by revision surgery on (b)(6) 2021.The physician removed the old patella button, cleaned off the remaining cement, cleared away any scar/fibrotic tissue, did a lateral release and repositioned a new patella button.Current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without the requested information, currently unable to rule out ¿the tibial component was placed about 8mm of internal rotation¿ as a contributing factor to the severe lateral knee pain, patella malposition/tracking/loosening, hemarthrosis and revision cannot be definitively concluded.The patient impact beyond the reported symptoms and revision cannot be determined, as no imaging was provided for review.Therefore, no further clinical medical assessment can be rendered.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 revealed similar events for the listed device, but no similar events for the batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.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.Possible causes could include but not limited to surgical technique used, size of device, user/procedural variance or traumatic injury.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.

• Brand Name: GNS II RESURF PAT 35MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• 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: 12878930
• Report Number: 1020279-2021-08429
• Device Sequence Number: 19951438
• Product Code: JWH
• UDI-Device Identifier: 03596010208316
• UDI-Public: 03596010208316
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71420578
• Device Catalogue Number: 71420578
• Device Lot Number: 17FM21535
• 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: 11/10/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 11/26/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2017
• 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: 74022128/JRNY II BCS FEMORAL OXIN LT SZ 8; 74022226/JOURNEY TIBIA BASE NP LT SZ 6
• Patient Sex: Male