MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR CR NP FEMORAL COMPSZ 4 RIGHT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	OR71420022
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on the patient due to instability.No additional injuries reported.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, no clinical relevant supporting documents were provided to conduct a thorough medical assessment of the reported instability.Without the surgical findings, medical documents, x-rays, or explants for analysis the root cause of the reported instability cannot be definitively concluded.The future impact to the patient cannot be determined.Based on the information provided no further clinical assessment is warranted at this time.Should additional information be provided, the clinical/medical investigation task will be reopened.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GEN II COCR CR NP FEMORAL COMPSZ 4 RIGHT
• 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: 8368401
• Report Number: 1020279-2019-00792
• Device Sequence Number: 13849969
• Product Code: JWH
• UDI-Device Identifier: 03596010205544
• UDI-Public: 03596010205544
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: OR71420022
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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