MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXINIUM FEM SIZE 4 RIGHT; U.V. METHOD, CPK ISOENZYMES

Catalog Number	71420150
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Pain (1994)
Date of Event	01/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an aspiration was performed for cell count due to pain.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, based on the documents provided and reviewed, arthrofibrosis and aseptic loosening of the tibial baseplate is the root cause of the revision.The root cause of the patient¿s continued post-revision right foot issues cannot be determined; however it was noted by the surgeon that ¿it is really rare to have a tibial nerve issue in the plantar aspect of the foot from a knee replacement.¿ a review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.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 OXINIUM FEM SIZE 4 RIGHT
• Common Device Name: U.V. METHOD, CPK ISOENZYMES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8200161
• Report Number: 1020279-2018-02915
• Device Sequence Number: 16193567
• Product Code: JWH
• UDI-Device Identifier: 03596010430175
• UDI-Public: 03596010430175
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K962557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: 04/18/2025
• Device Catalogue Number: 71420150
• Device Lot Number: 15DM14000
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 04/17/2019
• 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: 58 YR