MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEXION INSERT SZ 7-8 9MM; PRSTHSIS,KNEE,PATLLOFMROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	71421522
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure the insert could be put into the patient but couldn't lock tightly, when bended the patient knee, it would be dislocated.The surgical time was extended for 40 minutes.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A clinical analysis indicated that it has been communicated via email that no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.A lab analysis indicated minor deformation was observed on the periphery of the articulating surface of the insert.Minor scratches were observed on the inferior surface and signs of deformation were present on the anterior surface.The anterior deformation damage could have likely been caused during removal of the insert.There were no observations of material or manufacturing deviations in the course of this investigation.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.The features that could be measured were within specification.A clinical analysis indicated that it has been communicated via email that no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the listed parts did not reveal additional complaints for the listed batches.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.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: GII PS HIGH FLEXION INSERT SZ 7-8 9MM
• Common Device Name: PRSTHSIS,KNEE,PATLLOFMROTIBIAL,SMI-CNSTRAIND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7563996
• Report Number: 1020279-2018-01031
• Device Sequence Number: 2194109
• Product Code: JWH
• UDI-Device Identifier: 03596010492975
• UDI-Public: 03596010492975
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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: 02/26/2024
• Device Catalogue Number: 71421522
• Device Lot Number: 14BM21895
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/02/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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: Other
• Patient Age: 75 YR