MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE, UHMPWE,9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number	400143F
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/13/2019
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
A star ankle poly swap was reported due wear on insert.
Additional Manufacturer Narrative
Correction: device identification (lot #).The reported event could be confirmed.More detailed information about the complaint event such as x-rays, patient data, patient activity levels as well as the implantation and explantation dates must be available in order to determine the root cause of the complaint event.The explanted sliding core was transferred to an external lab.The visual inspection revealed that the sliding core was deformed in that way that the rectangle form was no longer given.The deformation was caused by axial pressure postoperatively.Furthermore one edge of the sliding core was found slightly abraded, making the device improper to stay implanted.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.
Event or Problem Description
A star ankle poly swap was reported due wear on insert.

• Brand Name: SLIDING CORE, UHMPWE,9MM
• 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: 8422648
• Report Number: 0008031020-2019-00273
• Device Sequence Number: 19279016
• Product Code: NTG
• UDI-Device Identifier: 00886385026954
• UDI-Public: 00886385026954
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P050050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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: 06/30/2021
• Device Catalogue Number: 400143F
• Device Lot Number: 1546195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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 Weight: 85