MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R ART INS SZ7-8 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71420514
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that after a bilateral tka on (b)(6) 2016, plaintiff presented anterior femoral resurfacing component lucency, arthritic varus knee deformity, increased of heterotopic ossification along the posterior knee and superior/inferior patella on the left side and pain in the groin.Plaintiff had a polyethylene insert fracture.Plaintiff underwent revision surgery on (b)(6) 2021 where the insert was explanted.The outcome of the plaintiffs is unknown.
Additional Manufacturer Narrative
The device was not returned for evaluation but the pictures were reviewed, and the broken device was confirmed.The clinical/medical investigation concluded that, the revision was due to mechanical instability/insert post component failure; however, the patient activity which led to the (b)(6) 2021 ed visit after a workout could not be ruled out as a potential contributing factor to the reported event.Additionally, the relatively stable lucencies and progression of heterotopic ossification and djd reported on x-rays may have also contributed to the reported pain, although not indicative of a component malperformance.The assessed patient impact was the reported symptoms, clinical findings, revision, and an anticipated transient post-op recovery.Further patient impact cannot be determined.No further medical assessment can be rendered at this time.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device revealed that fracture of implant has been identified in possible adverse effects section as a result of trauma, strenuous activity, improper alignment, or duration of service.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.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.The contribution of the device to the reported event could be corroborated since the device broke, therefore, it could not function correctly anymore.Based on this investigation, the need for corrective action is not indicated.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: GII C/R ART INS SZ7-8 13MM
• 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: 13777674
• Report Number: 1020279-2022-01192
• Device Sequence Number: 17077091
• Product Code: JWH
• UDI-Device Identifier: 03596010208019
• UDI-Public: 03596010208019
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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: 71420514
• Device Catalogue Number: 71420514
• 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: 02/24/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 04/18/2022
• 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: Required Intervention; Hospitalization; Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 109 KG