MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 RT11; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74023273
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was unstable, during the revision the post was found to be broken.It was replaced with a revision insert.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The post on the device was damaged / worn.A small section of the post fractured off and was returned.The device also had numerous scratches, nicks and gouges from extraction.The device was manufactured in 2009.A dimensional inspection was attempted but the device was too damaged from wear and extraction to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The clinical/medical investigation concluded that since no clinically relevant documentation was provided so a thorough medical investigation could not be performed.Per the product evaluation / visual inspection, the stated failure mode was confirmed; however, the ¿device was too damaged from wear and extraction to obtain accurate measurements¿ for a dimensional inspection.Without clinical documentation, the patient impact beyond the reported instability and the revision procedure with an expected post-op rehab phase cannot be determined.No further medical assessment is warranted 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.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 7-8 RT11
• 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: 8478886
• Report Number: 1020279-2019-01351
• Device Sequence Number: 1253377
• Product Code: JWH
• UDI-Device Identifier: 03596010555298
• UDI-Public: 03596010555298
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2019

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: 74023273
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/04/2019
• 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