MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS INSERT SZ 5-6 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SMI-CONST, CMENTD, POLY/MTAL/POLY

Catalog Number	71420830
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that once the definitive implants were placed (femur, tibia), the device 71420830 batch h1817411 was placed.Extension tests were carried out and after the flexion, the device throw away.3 attempts were made with the device unsuccessfully and a smaller insert was used in order to complete the procedure.This is the second complaint with same problem in the same procedure.First was with the item (b)(4) batch h1813400 and second was this.Procedure was completed using a back up device.No damage to patient occurred.Procedure was completed succesfully.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: GII PS INSERT SZ 5-6 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SMI-CONST, CMENTD, POLY/MTAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8888655
• Report Number: 1020279-2019-03033
• Device Sequence Number: 311125
• Product Code: JWH
• UDI-Device Identifier: 03596010209641
• UDI-Public: 03596010209641
• Combination Product (Y/N): N
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71420830
• Device Lot Number: H1817411
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1