MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 26MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420580
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2010 with a genesis ii system, the patient experienced instability in the knee for a couple of months.This adverse event was addressed via revision surgery on (b)(6) 2022.Upon inspection, it was noticed that the gns ii resurf pat 26mm was loose.Patient current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The clinical/medical evaluation concluded that based on a review of the two undated, unlabeled photos of the explant, two of the chart sticks, and two undated, unlabeled x-ray photos were provided but do not indicate a root cause of the broken insert post.The revision finding of the reported loosening was confirmed to be related to the broken post.However, the patient¿s body habitus of 238 pounds could not be ruled out as a possible contributory factor.Per the ifu for the knee systems; ¿the implant can break or become damaged because of strenuous activity or trauma and has a finite expected service life and may need to be replaced in the future.¿ it should also be noted the implant was implanted 12 years prior to the revision.According to the report, the patient¿s current health status is unknown.Therefore, the patient impact beyond the instability, the revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.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 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 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.The contribution of the device to the reported event could not be corroborated.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file.This event was evaluated by our quality team and the evaluation could not confirm this failure as a result of a non conforming product, as the device was found to be too damaged from prolonged use.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.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The clinical/medical evaluation concluded that based on a review of the two undated, unlabeled photos of the explant, two of the chart sticks, and two undated, unlabeled x-ray photos were provided but do not indicate a root cause of the broken insert post.The revision finding of the reported loosening was confirmed to be related to the broken post.However, the patient¿s body habitus of 238 pounds could not be ruled out as a possible contributory factor.Per the instruction for use for the knee systems; ¿the implant can break or become damaged because of strenuous activity or trauma and has a finite expected service life and may need to be replaced in the future.¿ it should also be noted the implant was implanted 12 years prior to the revision.According to the report, the patient¿s current health status is unknown.Therefore, the patient impact beyond the instability, the revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.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 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 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.The contribution of the device to the reported event could not be corroborated.Factors that could contribute to the reported event include traumatic injury, size selected, postoperative care.This event was evaluated by our quality team and the evaluation could not confirm this failure as a result of a non conforming product, as the device was found to be too damaged from prolonged use.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: GNS II RESURF PAT 26MM
• 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: 15136591
• Report Number: 1020279-2022-03550
• Device Sequence Number: 14730118
• Product Code: JWH
• UDI-Device Identifier: 03596010208323
• UDI-Public: 03596010208323
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2022

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: 02/26/2020
• Device Model Number: 71420580
• Device Catalogue Number: 71420580
• Device Lot Number: 10BM10026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 11/17/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 11/07/2022; 11/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2010
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 108 KG