MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII C/R ART INS SZ 3-4 9MM; PROSTHESIS KNE PATELOFEMOROTIBIAL SEMI-CONSTRAINED CEMNTD POLYMERMETALPOLYMER

Catalog Number	71420490
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the insert could not be implanted, backup used not from smith and nephew.Delay 0-30 min and no injury reported.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned insert indicated damage to the locking detail, dovetail, and on the locking face.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.The features that could be measured were within specification.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.No additional actions are being taken at this time; however, we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII C/R ART INS SZ 3-4 9MM
• Common Device Name: PROSTHESIS KNE PATELOFEMOROTIBIAL SEMI-CONSTRAINED CEMNTD POLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8203852
• Report Number: 1020279-2018-02933
• Device Sequence Number: 1657397
• Product Code: JWH
• UDI-Device Identifier: 03596010207890
• UDI-Public: 03596010207890
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

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 Catalogue Number: 71420490
• Device Lot Number: 18EM00341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR