MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXIN P/S FEM LEFT SZ 6; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL

Catalog Number	71421016
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/30/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient twisted his knee and developed bleeding.An aspiration was performed with only anti-inflammatory medication.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Our investigation including a review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Without the return of the actual products involved, our investigation of this report is inconclusive.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.Should additional information become available this complaint can be re-assessed.

• Brand Name: GII OXIN P/S FEM LEFT SZ 6
• 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: 7509853
• Report Number: 1020279-2018-00923
• Device Sequence Number: 1242557
• Product Code: JWH
• UDI-Device Identifier: 03596010469229
• UDI-Public: 03596010469229
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K962557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2018

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 Catalogue Number: 71421016
• Device Lot Number: 15EM07730
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 10/07/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 93