MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CON INS SZ 3-4 18MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Catalog Number	71420530
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to joint instability.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and without the requested clinical information, labs, radiographs, fall history or the explant the root cause of the joint instability cannot be determined and based on the information available this would not be a device failure.The future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.

• Brand Name: GNS II CON INS SZ 3-4 18MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8147257
• Report Number: 1020279-2018-02738
• Device Sequence Number: 1502047
• Product Code: JWH
• UDI-Device Identifier: 03596010208071
• UDI-Public: 03596010208071
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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: 71420530
• Device Lot Number: D1604226
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 11/12/2019
• 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: 64 YR