MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 LT 9; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74023281
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was walking with a brace and was dislocating the knee actively.The event resulted in revision surgery to remove the insert.It was found that the upper tip of the post of the bcs insert had broken off.
Additional Manufacturer Narrative
H10: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical / medical team noted: without the relevant supporting clinical information, a thorough medical investigation cannot be rendered at this time.Therefore, the impact to the patient beyond the revision cannot be determined.No further medical assessment can be rendered at this time.Should any additional medical information be provided this complaint will be re-assessed.A definite root cause could not be determined with the information provided.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 7-8 LT 9
• 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: 9770374
• Report Number: 1020279-2020-00726
• Device Sequence Number: 11415956
• Product Code: JWH
• UDI-Device Identifier: 03596010555342
• UDI-Public: 03596010555342
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2021

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 Model Number: 74023281
• Device Catalogue Number: 74023281
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 11/11/2020; 09/24/2021
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 11/16/2020; 09/27/2021
• 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