MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN II COCR PS NP FEMORAL COMPSZ 7 RIGHT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420124
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, there was a dent in the side of the femur.It was not possible to fix the implant impactor due to the dent.Because of low stock (back orders) it was not possible to return the implant.The surgeon implanted the device free hand.No injuries reported.A delay no longer than 30 min was reported.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: GEN II COCR PS NP FEMORAL COMPSZ 7 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: 8787550
• Report Number: 1020279-2019-02661
• Device Sequence Number: 19343619
• Product Code: JWH
• UDI-Device Identifier: 03596010206060
• UDI-Public: 03596010206060
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71420124
• Device Catalogue Number: 71420124
• Device Lot Number: 19AM22263
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 07/14/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1