MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71421501
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a literature review, that at 32 weeks of primary surgery the patient complained of a sudden onset of knee pain associated with restricted range of motion.During physical examination, an audible popping sound was emanated from a swollen right knee.The patient referred that a week earlier he had suffered a half-meter fall from a bus with both knees held in semiflexion.
Additional Manufacturer Narrative
The associated complaint device was not returned.A medical investigation concluded that based on the article, the first revision was precipitated by the dislocation of the insert secondary to a fall from a bus.The root cause of the methicillin-resistant staphylococcus aureus that resulted in the second revision cannot be concluded, but is not due to a failure of the device or procedure.Without supporting clinical/medical documents a thorough investigation cannot be performed.In addition, without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GII PS HIGH FLEXION INSERT SZ 1-2 9MM
• 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: 7996030
• Report Number: 1020279-2018-02254
• Device Sequence Number: 19177743
• Product Code: JWH
• UDI-Device Identifier: 03596010492388
• UDI-Public: 03596010492388
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K032295
• 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): 05/04/2019

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: 71421501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 05/04/2019
• 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: Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 80