MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 1-2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420804
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
After bone cement hardened, the 1-2/11mm insert, was not able to effectively mount on the baseplate.Baseplate was the 2 right.Cleaned the soft tissue around the baseplate several times, tried to mount several times, still failed.Consideration of patient safety, changed a 1-2/9mm insert to complete the surgery, the joint was slightly loose.12mins delay.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A lab analysis indicated that the exact cause of the anterior lock detail deformation and anterior surface scratches and deformation could not be determined from the investigation of the device.The posterior lock detail appears undamaged.There were no observations of material or manufacturing deviations in the course of this investigation.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 part.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.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII PS INSERT SZ 1-2 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7632767
• Report Number: 1020279-2018-01183
• Device Sequence Number: 1754910
• Product Code: JWH
• UDI-Device Identifier: 03596010209511
• UDI-Public: 03596010209511
• 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): 12/22/2018

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: Physician
• Device Catalogue Number: 71420804
• Device Lot Number: 17FM20703
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/24/2018
• Supplement Report FDA Received Date: 12/22/2018
• 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: Hospitalization
• Patient Age: 65 YR
• Patient Weight: 56