MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HI FLEX ISRT W/ JRNY LK SZ 3-4 13; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71933734
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during revision surgery of a cr femoral component, the gii ps high flexion insert sz 3-4 13mm would not lock in the front after multiple attempts.Procedure continued with a backup device from smith and nephew of different size.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode, but confirmed the device has small cuts and scratches on the inferior surface of the insert.A dimensional inspection was attempted but the device was too damaged from the attempted insertion to obtain accurate measurements.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 review of complaint history did not reveal additional complaints for the listed device.Our clinical/medical team noted: this case reports that during a revision surgery, the insert would not lock into the baseplate after several attempts.Per complaint details, there was no patient injury and the procedure was completed a backup device without delay.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint, however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII PS HI FLEX ISRT W/ JRNY LK SZ 3-4 13
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11095034
• Report Number: 1020279-2020-08020
• Device Sequence Number: 3698395
• Product Code: JWH
• UDI-Device Identifier: 00885556064559
• UDI-Public: 885556064559
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71933734
• Device Lot Number: 19BM20697
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1