MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT SZ 5-6 11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421516
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Pain (1994); Joint Laxity (4526)
Date of Event	05/23/2022
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 surgery had been performed on 2010, the patient fell on his tka.The patient presented with pain and instability in the clinic.A revision surgery was performed on the (b)(6) 2022 to treat this adverse event.During the surgery, it was revealed that the top post of the gii ps hi flex isrt sz 5-6 11 had fractured off and was lodged in soft tissue in the notch.All pieces were successfully removed and a new ps standard poly was implanted.The patient status is unknown.
Event or Problem Description
It was reported that, after a tka surgery had been performed on 2010, the patient fell on his tka.The patient presented with pain and instability in the clinic.A revision surgery was performed on the (b)(6) 2022 to treat this adverse event.During the surgery, it was revealed that the top post of the gii ps hi flex isrt sz 5-6 11 had fractured off and was lodged in soft tissue in the notch.All pieces were successfully removed and a new ps standard poly was implanted.The patient is recovering well.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be fractured along the post, rendering the device inoperative.The device was also found to be discolored from exposure to bodily fluids.The fracture post was returned as well.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that the four undated, unlabeled photos, two of the inserts with the broken post, and two intra-operative photo of the open knee that revealed the broken insert, along with the chart sticks support the reported failure.The root cause of the reported failure could not be confirmed.The reported fall and the patient body habitus of 340 pounds are possible contributory factor; ¿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 be noted the implant was implanted 12 years prior to the revision and the patient is recovering well.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted 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.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 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 traumatic injury, abnormal loading of the limb, or implant failure.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 5-6 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: 14638969
• Report Number: 1020279-2022-02814
• Device Sequence Number: 12201703
• Product Code: JWH
• UDI-Device Identifier: 03596010492333
• UDI-Public: 03596010492333
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2022

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 Model Number: 71421516
• Device Catalogue Number: 71421516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 06/16/2022; 07/15/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 06/20/2022; 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Weight: 154 KG