MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS II SPC F/E SZ GDE; PROSTH, KNEE, PATE/FEMOROTIBIAL, SUNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number	71933043
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the balance measurement tool of the knee joint did no mark the line, and it cannot correctly mark the osteotomy.There was not an s&n backup device available and the surgeon had to use regular tools instead and divert from the original procedure.The surgery was completed successfully with no delay or patient injuries.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned genesis ii spc flexion/extension gap balancing sizing guide indicated that all laser etching was present to print.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed part did not reveal additional complaints for the listed batch.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned genesis ii spc flexion/extension gap balancing sizing guide indicated that a laser mark is missing, confirming the stated complaint.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed part did not reveal additional complaints for the listed batch; hence we consider this an isolated event.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GENESIS II SPC F/E SZ GDE
• Common Device Name: PROSTH, KNEE, PATE/FEMOROTIBIAL, SUNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8452269
• Report Number: 1020279-2019-01181
• Device Sequence Number: 2989015
• Product Code: MBH
• UDI-Device Identifier: 00885556059951
• UDI-Public: 00885556059951
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2019

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: 71933043
• Device Lot Number: 16KCT0009
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019; 03/04/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/16/2019; 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1