MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 4 {} RIGHT; PROSTHESIS, KNEE, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Model Number	OR71420184
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had sn components since (b)(6) 2014.Revision surgery performed on (b)(6) 2019 due to complete loosening and massive abrasion metallosis.
Additional Manufacturer Narrative
Additional info.
Additional Manufacturer Narrative
The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices could not confirm the stated failure mode.The devices have signs of damage and wear from implantation and extraction.The devices were manufactured in 2014.The medical investigation concluded that, without radiological imaging and supporting lab/pathology results, the definitive root cause of the reported loosening could not be concluded; although the reported pain, ¿metallosis¿ and ¿inlay wear¿ were most likely secondary to said loosening.It is unknown if the ¿sparingly covered¿ cemented primary components contributed to the reported femoral component loosening and/or if the denervation of the patella with osteotomy could have possibly contributed to the reported disabling pain.The results of the product evaluation could not confirm the reported failure mode as all were within specifications.The patient impact beyond the reported symptoms, intra-op findings and revision itself could not be determined.No further medical assessment could be rendered at this time.The dimensional evaluation found the mating features of the devices to be within specification.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include a procedural error or a traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.

• Brand Name: GNS II CMT TIB SIZE 4 {} RIGHT
• Common Device Name: PROSTHESIS, KNEE, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9824464
• Report Number: 1020279-2020-00848
• Device Sequence Number: 11530005
• Product Code: JWH
• UDI-Device Identifier: 03596010206343
• UDI-Public: 03596010206343
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/20/2021

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: No Information
• Device Expiration Date: 08/05/2024
• Device Model Number: OR71420184
• Device Catalogue Number: OR71420184
• Device Lot Number: 14HT44968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 08/05/2020; 08/05/2020; 05/12/2021
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 08/20/2020; 08/31/2020; 05/20/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR