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

Model Number	74023271
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after surgery, right tkr, the patient suffered from pain, discomfort and repetitive bleeding episodes.Arthroscopic examination and knee debridement were performed with no infection confirmed, this providing only temporal relief, resulting in revision surgery due to poly breakage.
Additional Manufacturer Narrative
Results of investigation: the devices, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The devices were manufactured in 2007 and 2008.A review of the device history records for the listed batches did not reveal any deviation from the standard manufacturing processes.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 has been identified.Our clinical/medical team noted: this patient¿s bilateral primary surgery was performed in july 2008.The patient presented acute spontaneous hemarthrosis in june 2009.The left knee had two episodes of spontaneous bleeding.The right knee presented repetitive bleeding and possible infection.This resulted in an arthroscopic examination and knee debridement; (no infection was confirmed) this provided only temporal relief in july 2009.The exact date of the revision surgery for the broken insert in unknown.No clinical/medical documentation has been provided.Without supporting documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Impact to the patient cannot be determined based on the limited information.The root cause cannot be concluded with the information available.Based on this investigation, the need for corrective action is not indicated.Without the products 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 RT 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: 9795125
• Report Number: 1020279-2020-00805
• Device Sequence Number: 16787744
• Product Code: JWH
• UDI-Device Identifier: 03596010555274
• UDI-Public: 03596010555274
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: 02/19/2017
• Device Model Number: 74023271
• Device Catalogue Number: 74023271
• Device Lot Number: 07BM12501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 11/12/2020
• 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
• Patient Weight: 115