MAUDE Adverse Event Report: STRYKER GMBH SLIDJNG CORE, UHMPWE,8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Model Number	400-142F
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
Patient presented with pain and swelling.On x-ray the mobile bearing was displaced.
Event or Problem Description
Patient presented with pain and swelling.On x-ray the mobile bearing was displaced.
Additional Manufacturer Narrative
The reported event that slidjng core, uhmpwe,8mm was alleged of 'fusion' could not be confirmed, since no x-ray showing the fusion of the bones was returned for evaluation.The device inspection revealed the following: the sliding component was returned and a visual inspection shows residues of soft tissues and blood on the device.Overall, the device is heavily damaged: the pe surrounding the groove of the mobile bearing is very deformed, as well as the pe on one of the corners of the device.The deformation level on the returned piece is as if the plastic "melted".On one of the longer sides of the mobile bearing, the plastic layer deformed/disappeared to the point of having the x-ray wire show clearly.For this case, since some radiographs of the implanted patient were returned, the medical opinion of stryker's medical expert was requested.Their statement is the following: " [.] the radiographs show that there is a complete collapse of the talar dome with massive subsidence of the talar component into the talus.This resulted in a malalignment of the poly between the talar and tibial component resulting of major wear of the poly over the period 2014-18.The failure is related to the initial subsidence.[.]" a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

• Brand Name: SLIDJNG CORE, UHMPWE,8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7379608
• Report Number: 0008031020-2018-00245
• Device Sequence Number: 18864061
• Product Code: NTG
• UDI-Device Identifier: 00886385026947
• UDI-Public: (01)00886385026947
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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: Lay User/Patient
• Device Expiration Date: 06/30/2016
• Device Model Number: 400-142F
• Device Catalogue Number: 400142F
• Device Lot Number: 1412130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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: Required Intervention
• Patient Age: 78 YR