MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE UHMPWE, 6MM; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number 400140

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.

Event Description

As reported: "doctor reports a fracture of a star glide core at a height of 6 mm at the right ankle joint.Revision will probably take place in 2 weeks".

Manufacturer Narrative

Corrections: please refer to sections d9/h3, the device has been explanted and returned.The reported event could be confirmed since the broken implant was returned.The device was returned and is in a poor state.The sliding core is indeed broken perpendicularly to the sliding groove, into at least three pieces.The sides of the returned sliding core also show compressive deformation which proves that the implant withstood pressure for an extensive amount of time (11 years of implantation) before it broke.Based on this inspection, the normal wear of the device following 11 year of use is part of the root cause of the event.However, more detailed information about the complaint event such as x-rays must be available in order to determine the complete 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 complaint report will be updated.

Event Description

As reported: "doctor reports a fracture of a star glide core at a height of 6 mm at the right ankle joint.Revision will probably take place in 2 weeks".Additional information: revision surgery took place on (b)(6) 2021.

• Brand Name: SLIDING CORE UHMPWE, 6MM
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11548323
• MDR Text Key: 241758799
• Report Number: 0008031020-2021-00099
• 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: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 400140
• Device Lot Number: 0907136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR