MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN STAR TALAR COMPONENT; IMPLANT

Catalog Number UNK_SEL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Pain (1994)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Right ankle pain was reported to surgeon by patient.Ct shows cystic area under the talar component.Revision surgery occurred as a result.

Event Description

Right ankle pain was reported to surgeon by patient.Ct shows cystic area under the talar component.Revision surgery occurred as a result.

Manufacturer Narrative

The reported event could not be confirmed only based on the x-rays.However, the loosening of the implant could be noticed.Based on investigation, the root cause of the cysts is the loosening of the implant.In the case presented a patient had been treated with star in (b)(6) 2011.On (b)(6) 2019 the patient had to be revised as they were having pain in the ankle.A ct scan (which was not provided) showed a cystic area under the talar component.This root cause was determined after review of the x-rays and the details of this case.Device disposition unknown.

• Brand Name: UNKNOWN STAR TALAR COMPONENT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8571239
• MDR Text Key: 143803559
• Report Number: 0008031020-2019-00383
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR