MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 3-4 13MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRIND,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	71420820
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a surgery the insert did not lock into the left tibial baseplate.It was found that the trailing edge of the insert and the joint of tibial baseplate did not match.The total delay of the surgery was 70 minutes and another device was used to complete the surgery.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned insert indicated surface damage and damage to the locking detail and distal face.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 clinical analysis indicated that based on the information provided, the connection problem was likely related to the procedure to implant the s&n device and not due to the s&n device itself.The surgery completed with a back-up device.Reportly, the patient is now doing well; therefore, no further harm to the patient has been anticipated.No further clinical/medical assessment is warranted at this time.A review of complaint history on the listed part revealed no additional complaints for the listed batch.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: GII PS INSERT SZ 3-4 13MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRIND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7028069
• Report Number: 1020279-2017-01019
• Device Sequence Number: 1183678
• Product Code: JWH
• UDI-Device Identifier: 03596010209597
• UDI-Public: 03596010209597
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2018

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 Expiration Date: 01/26/2026
• Device Catalogue Number: 71420820
• Device Lot Number: 16AM19729
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 11/01/2017; 11/01/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 04/24/2018; 04/25/2018
• 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: Other
• Patient Age: 72 YR