MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 3-4 11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421509
Medical Device Problem Code	Fracture (1260)
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 post was broken off of the gii ps hi flex isrt sz 3-4 11.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 confirmed the stated failure mode.The device post is fractured.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.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.As the device broke and it can no longer fit its purpose, the contribution of the device to the reported event could be corroborated.Some potential probable causes for this event could include but not limited to wear, traumatic injury and device lifetime.A clinical evaluation for the device was conducted, and 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.This event was evaluated by our quality process for nonconforming product.The returned product showed a broken post from the body of the insert.Based on provided surgical history, the implant was in use for over 12 years.No dimensional information can be gathered from the returned product due to multi-year use in the patient and the subsequent wear experienced during this time period.A complaint search indicated no further complaints for this batch.The details provided by the clinical/medical evaluation team provide a clear summary of the situation surrounding the implant, patient, and potential multitude of factors that could have lead to this device failure.At this time, no further escalation activities will be pursued.If additional complaints are filed for the batch, this record will be reviewed and considered.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: GII PS HI FLEX ISRT SZ 3-4 11
• 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: 15136589
• Report Number: 1020279-2022-03549
• Device Sequence Number: 5048236
• Product Code: JWH
• UDI-Device Identifier: 03596010492364
• UDI-Public: 03596010492364
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K032295
• 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
• Report Date (Section B): 10/26/2022

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: 01/24/2020
• Device Model Number: 71421509
• Device Catalogue Number: 71421509
• Device Lot Number: 10AM12397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/25/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2010
• 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