MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 LT10; PROSTHSIS,KNEE,PTLLFEMRTIBIL,SMICONSTRAIND,CMNTED,POLYMR/METAL/POLYMR

Model Number	74023282
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due the journey art ins bcs standard 7-8 left 10 was broken and patient complaint of instability.The device was implanted in (b)(6) 2007.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.A small section of the post on the device fractured off and was returned.The device is heavily worn with discoloration and pitting on the articular surface.The bottom side of the device is also very worn with nicks, scratches and discolored areas.The knee insert post fracture may have been due to repeated posterior contact of the femoral cam on the post combined with excessive posterior to anterior shear force during activity.However, this could not be isolated as the root cause for this particular failure mode.The medical investigation concluded that the definitive root cause of the reported left knee pain, popping, locking and instability cannot be concluded; although it is known that laxity can occur over time given the device age of greater than 13 years.The patient¿s body habitus, applications of loads in excess of the material¿s strength and bone density changes over time cannot be excluded as contributory factors.The provided radiographic images and product evaluation support the reported failure of instability.The patient impact beyond the reported patient symptoms and subsequent revision could not be determined.No further clinical/medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include a fit/sizing issue, overuse or a traumatic injury.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: JOURN ART INS BCS STD 7-8 LT10
• Common Device Name: PROSTHSIS,KNEE,PTLLFEMRTIBIL,SMICONSTRAIND,CMNTED,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9960458
• Report Number: 1020279-2020-01301
• Device Sequence Number: 2808736
• Product Code: JWH
• UDI-Device Identifier: 03596010555359
• UDI-Public: 03596010555359
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2020

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 Model Number: 74023282
• Device Catalogue Number: 74023282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 06/27/2020
• 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 Age: 48 YR
• Patient Weight: 145