MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 LT11; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74023283
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision was performed to perform a poly exchange, due to the patient suffering a dislocation.Additionally, a fragment of the post broke off so it was removed from the knee and replaced with a journey high post.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.The visual inspection of the returned device confirmed the stated failure mode.The device had some abrasions, discoloration and deformation on the bearing regions on the superior surface.Scratches and material wear were observed on the inferior surface of the device and some material damage could be seen around the periphery of the device.The device fractured near the top of the post.Significant material deformation was present on the device around the fracture surface.The medical investigation concluded that, per the product evaluation/lab retrieval analysis, ¿the fracture could have been caused due to repeated posterior impingement of the femoral cam on the post combined with excessive loads¿; however, this could not be definitively concluded.No material or manufacturing deviations were observed in the process of their investigation.The patient impact beyond the reported revision due to dislocation and post breakage could not be determined.No further medical assessment can be rendered at this time.Based on this investigation, the need for corrective action is not indicated.Should 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.

• Brand Name: JOURN ART INS BCS STD 7-8 LT11
• 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: 8881925
• Report Number: 1020279-2019-02985
• Device Sequence Number: 18904748
• Product Code: JWH
• UDI-Device Identifier: 03596010555366
• UDI-Public: 03596010555366
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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 Catalogue Number: 74023283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 08/11/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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: 64 YR