MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 3-4 11MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420818
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, insert was unable to be inserted properly.Alternative implants from smith and nephew were used in the surgery.Delay of less than 30 minutes, patient did not suffer.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device had some minor damage from the attempted insertion into the mating part.The device was manufactured in 2018.A dimensional inspection was attempted but the device was too damaged/ deformed from the attempted implantation to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have contributed to the reported incident.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.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PS INSERT SZ 3-4 11MM
• 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: 8534331
• Report Number: 1020279-2019-01606
• Device Sequence Number: 2431603
• Product Code: JWH
• UDI-Device Identifier: 03596010209580
• UDI-Public: 03596010209580
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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: 71420818
• Device Lot Number: 18HT08408
• Initial Date Received by Manufacturer: 03/30/2019
• Supplement Date Received by Manufacturer: 03/30/2019
• Initial Report FDA Received Date: 04/21/2019
• Supplement Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1