MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 29MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71421029
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/29/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a left pfj surgery had been performed on (b)(6) 2015, the patient experienced extreme daily pain.Since then, the patient have had 7 unspecified surgeries to address the pain.On (b)(6) 2021 the patient underwent a revision surgery and the hardware that was taken out of the knee was very damaged.The patient is in recovery.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a left pfj surgery had been performed on (b)(6) 2015, the patient experienced extreme daily pain.Since then, the patient have had 7 unspecified surgeries to address the pain.On (b)(6) 2021 the patient underwent a revision surgery and the hardware that was taken out of the knee was very damaged.The patient is in recovery.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.The clinical/medical investigation concluded that based on the information provided, the root cause of the reported ¿the patient experienced extreme daily pain,¿ cannot be definitively concluded, however, cannot rule out the mixed manufacturer components as a potential contributing factor, as per the knee systems ifu no component substitutions allowed.The patient impact beyond the reported extreme daily pain, revision, and unspecified surgeries cannot be determined and the patient¿s current health status is reportedly ¿the patient is in recovery.¿ therefore, no further clinical medical assessment can be rendered.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.A review of the instructions for use documents for knee systems reveal that each total knee system is designed as a system and does not allow the substitution of components from other systems or manufacturers.Also, the warnings and precautions section establishes that the implant can become damaged as a result of strenuous activity or trauma.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.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, lifetime of device and/or mixed manufacturer components.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 OVAL RESURFACING PAT 29MM
• 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: 13591514
• Report Number: 1020279-2022-00849
• Device Sequence Number: 3926725
• Product Code: JWH
• UDI-Device Identifier: 03596010485052
• UDI-Public: 03596010485052
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• 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): 03/25/2022

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 Model Number: 71421029
• Device Catalogue Number: 71421029
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 03/22/2022; 03/23/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 03/23/2022; 03/25/2022
• 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
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 73 KG