MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 32MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421032
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	11/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented bilateral pulmonary embolism after right total knee arthroplasty for which hospitalization and medical intervention was required.The patient had to receive remedial therapy to resolve the adverse event.
Additional Manufacturer Narrative
The associated journey ii bcs femoral oxinium, journey ii bcs articular insert, journey tibial baseplate and genesis ii oval resurfacing patella were not returned for evaluation.The complaint is that the patient had a bilateral pulmonary embolism after a right total knee arthroplasty, no devices were revised.Device details were provided so a review of the manufacturing records was conducted which did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that based on a review of clinical documentation provided, cultures that were taken of the knee and lungs were found to be negative.It was also reported the patient received prophylactic antibiotics as well as anticoagulant therapy.The root cause of the pulmonary embolus could have been a risk of the procedure itself (tka) the devices were not implicated.As such, no relationship between the devices and the reported incident or adverse event could be corroborated.The patient impact beyond the reported pain and need for extended hospital stay is inconclusive.The pulmonary embolism was resolved with medication.No further clinical assessment is warranted at this time.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.Should the devices or additional information be received, the complaint will be reopened and reevaluated.

• Brand Name: GII OVAL RESURFACING PAT 32MM
• 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: 8600429
• Report Number: 1020279-2019-01854
• Device Sequence Number: 1998276
• Product Code: JWH
• UDI-Device Identifier: 03596010485069
• UDI-Public: 03596010485069
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

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 Expiration Date: 08/10/2026
• Device Catalogue Number: 71421032
• Device Lot Number: 16HM09133
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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
• Patient Age: 66 YR
• Patient Weight: 76