MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 7-8 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420844
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered from pain.X-rays determined that the insert had broken.Revision surgery was performed to remove and replace the insert.
Additional Manufacturer Narrative
Additional info: d4, d10, g7, g9, h2, h3, h4, h6, h10.Results of investigation: it was reported that the patient suffered from pain.X-rays determined that the insert had broken.The affected legion ps articular insert, used in treatment, was returned and evaluated.A lab analysis conducted during this investigation noted signs of wear and deformation and a post fracture of the device.Some of the wear found on the articulating surfaces of the insert is due to contact with the femoral component.Some of the deformation found on the insert could have likely been caused by the explantation of the insert.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Possible causes of device fracture could include but not limited to traumatic injury, overuse or size of device.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved and no patient medical records, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
It was reported that the patient suffered from pain.X-rays determined that the insert had broken.The affected legion ps articular insert, used in treatment, was returned and evaluated.A lab analysis conducted during this investigation noted signs of wear and deformation and a post fracture of the device.Some of the wear found on the articulating surfaces of the insert is due to contact with the femoral component.Some of the deformation found on the insert could have likely been caused by the explantation of the insert.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Possible causes of device fracture could include but not limited to traumatic injury, overuse or size of device.Based on this investigation, the need for corrective action is not indicated.With no patient medical records provided, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII PS INSERT SZ 7-8 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9284321
• Report Number: 1020279-2019-03914
• Device Sequence Number: 11288799
• Product Code: JWH
• UDI-Device Identifier: 03596010209719
• UDI-Public: 03596010209719
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 71420844
• Device Catalogue Number: 71420844
• Device Lot Number: 13EM16032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/08/2019; 07/10/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 04/24/2020; 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention