MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII P/S ALL POLY TIB SZ3 11MM LT; PRSTHSS,KNEE,PATELLOFEMOROTIBIAL,SM CNSTRND,CEMENTED,POLYMER/METAL/POLYMER

Catalog Number	71420370
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had revision surgery, all poly tibia was loose and revised with a legion revision tibial baseplate, offset coupler, stem and pshf poly.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.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.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GII P/S ALL POLY TIB SZ3 11MM LT
• Common Device Name: PRSTHSS,KNEE,PATELLOFEMOROTIBIAL,SM CNSTRND,CEMENTED,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7636785
• Report Number: 1020279-2018-01201
• Device Sequence Number: 16555415
• Product Code: JWH
• UDI-Device Identifier: 03596010207289
• UDI-Public: 03596010207289
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K953274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

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: 01/16/2026
• Device Catalogue Number: 71420370
• Device Lot Number: 16AM11310
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 09/03/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention