MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II RESURF PAT 35MM; PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER

Model Number	71420578
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to un diagnosed pain.Implants were all well cemented scan was showing some sign of loosening in the tibia and patella, however intraoperatively everything well fixed.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to un-diagnosed pain.The affected genesis ii resurfacing patellar component, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.The instructions for use noted the alleged failure has been identified in the potential adverse events.A review of risk management files found that the reported failure was documented appropriately.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.At first it was thought there was some sign of loosening of the tibia and patella.However, intraoperatively it was discovered everything well fixed.Some potential causes of the reported event could include but are not limited to joint tightness or patient reaction.

• Brand Name: GNS II RESURF PAT 35MM
• Common Device Name: PRSTHSS, KNEE, PTLLFMRTBIAL, SM-CNSTRND, CMNTD, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10261767
• Report Number: 1020279-2020-03101
• Device Sequence Number: 16765505
• Product Code: JWH
• UDI-Device Identifier: 03596010208316
• UDI-Public: 03596010208316
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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 Model Number: 71420578
• Device Catalogue Number: 71420578
• Device Lot Number: 18EM17522
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 07/11/2020
• Supplement Report FDA Received Date: 09/21/2020
• 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