MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE UHMPWE, 8MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number 400142

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

Rep reported he received a call from the surgeon's office that there is a planned revision of a star ankle due to a broken poly.Surgery is scheduled for (b)(6) 2020 at the time of report.

Event Description

Rep reported he received a call from the surgeon's office that there is a planned revision of a star ankle due to a broken poly.Surgery is scheduled for 26/october/2020 at the time of report.

Manufacturer Narrative

The reported event could be confirmed.The device inspection revealed the following: the device was returned and is broken in two parts perpendicularly to the sliding groove.Aside from the breakage, the polyethylene was deformed on one of the four sides, along the surface with the ce 0123 marking, which proves that high mechanical loading has been applied to the implant on an extended period of time.However, more detailed information about the complaint event such as x-rays must be available in order to determine the root cause of the complaint event.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.Device disposition is unknown.

• Brand Name: SLIDING CORE UHMPWE, 8MM
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10813811
• MDR Text Key: 215592812
• Report Number: 0008031020-2020-02440
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 400142
• Device Lot Number: 1250137
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention