MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 6 {} LEFT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420170
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/30/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was treated due to left knee stiffness.The event was resolved via manipulation under anesthesia.
Additional Manufacturer Narrative
The associated complaint devices, used in treatment, were not returned for evaluation.A visual inspection could not be performed.A relationship between the device and the reported event could not be corroborated.No material or manufacturing deviations could be observed in this investigation because no product batch information was provided.A device history review could not be performed because no batch information was provided.A complaint history review found related failures; this failure mode will be trended by post market surveillance to assess for any necessary corrective actions.Factors that could have contributed to the event include swelling or improper device selection.Please refer to the instructions for use for recommendations on proper use of the device to prevent future reoccurrence of the reported event.The medical investigation concluded that no relevant clinical information has been provided to perform a thorough medical investigation.However, since it was reported the stiffness was resolved, no further clinical assessment is warranted at this time.Should any additional medical information be provided this complaint will be re-assessed.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/ or product information, our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: GNS II CMT TIB SIZE 6 {} LEFT
• 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: 9253232
• Report Number: 1020279-2019-03781
• Device Sequence Number: 2362652
• Product Code: JWH
• UDI-Device Identifier: 03596010206282
• UDI-Public: 03596010206282
• Combination Product (Y/N): N
• Initial Reporter Country: UG
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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: 71420170
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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