MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II 7.5MM RESUR PAT 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71932636
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Failure of Implant (1924); Arthralgia (2355)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after pfj reconstruction surgery had been performed on (b)(6) 2016, the patient experienced pain in the right knee after a fall.This adverse event was solved by converting to tkr on (b)(6) 2021.It was noticed that the journey pf implant med rt was cracked and the gen ii 7.5 mm resur pat 32 mm was eroded.Patient left surgery in good health.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The lab analysis concluded that the fracture of the pfj implant occurred perpendicular to the articular groove.Slight scratches were shown on the articular surface, which may have been caused by wear from third party particulates in vivo or by removal of the implant.Bone cement and bone were adhered to the bone interfacing surface, and the surrounding material had dents and gouges within it on the bare surfaces.Material damage on either side of the patella may have been a result of movement of the implant in vivo or caused during extraction.No material or manufacturing defects were observed during this investigation.A review of complaint history did not reveal similar events for the listed device.The clinical/medical evaluation concluded that per complaint details, the patient required revision/conversion to a right tka approximately 5 years post pfj implantation due to the onset of right knee pain ¿after a fall¿.Reportedly, findings intraoperatively revealed the pfj implant was ¿cracked¿ and the patella had eroded away.The requested medical documentation has not been provided as of the date of this medical assessment.Reportedly, the revision was performed due to pain ¿after the fall¿; however, the clinical root cause of the noted ¿cracked¿ pfj implant and ¿eroded¿ patella could not be definitively concluded based on the limited information provided.The patient impact beyond the reported pain, intraop component findings, and subsequent revision could not be determined.The patient reportedly ¿left surgery in good health/no injury¿.Further patient impact could not be concluded.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available and/or a product evaluation conclusion results in findings which are deemed clinically relevant, the clinical/medical task may be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.As the device was found to have damage, it's contribution to the reported event could be corroborated.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GEN II 7.5MM RESUR PAT 32MM
• 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: 12320869
• Report Number: 1020279-2021-06364
• Device Sequence Number: 4136711
• Product Code: JWH
• UDI-Device Identifier: 00885556056721
• UDI-Public: 885556056721
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 03/29/2026
• Device Catalogue Number: 71932636
• Device Lot Number: 16CM21891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown