MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 29MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	71420574
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient fell and then complained of pain in their knee.Upon seeing the patient, dr.Determined that the patient had damaged their pcl.The primary knee implants in the patients knee seemed to be loose.A revision was done to correct the patients knee pain.
Additional Manufacturer Narrative
The associated complaint devices were returned for evaluation.The visual inspection of the returned devices shows wear and damage on articular surface of the femoral component, also cement adhesion on bone / implant interface surface.The tibial insert shows surface wear on the articular surface.Damage was also on the inferior surface of the insert.The patellar component has articular surface wear, cement in the cement groove and damage to the cement surface.The tibial baseplate has damage on the anterior surface, cement on stem and fins and damage on the polished surface.A review of complaint history revealed no prior complaints for the listed lots.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A definitive root cause cannot be determined.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GNS II RESURF PAT 29MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7333309
• Report Number: 1020279-2018-00310
• Device Sequence Number: 759663
• Product Code: JWH
• UDI-Device Identifier: 03596010208293
• UDI-Public: 03596010208293
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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: 03/18/2021
• Device Catalogue Number: 71420574
• Device Lot Number: 11CM13938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2018
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 05/17/2018
• 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