MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII DISHED INS SZ 3-4 13MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420770
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dr.Was performing a primary tkr yesterday, (b)(6), when attempting to implant the tibial insert realized that there was a defect at the anterior lip superiorly.This looks like a gauge into the poly, depicted in the fourth image.He subsequently requested and implanted another insert.No injuries or delays reported.No more information available.
Additional Manufacturer Narrative
This complaint has been re-evaluated for mdr reporting.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: GII DISHED INS SZ 3-4 13MM
• 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: 8552928
• Report Number: 1020279-2019-01681
• Device Sequence Number: 2358534
• Product Code: JWH
• UDI-Device Identifier: 03596010209344
• UDI-Public: 03596010209344
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2019

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 Catalogue Number: 71420770
• Device Lot Number: 12BT15619
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 06/05/2019
• 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; Required Intervention