MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN STAR TIBIAL COMPONENT; PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED

Catalog Number UNK_SEL

Device Problem Loss of Osseointegration (2408)

Patient Problems Bacterial Infection (1735); Injury (2348)

Event Date 12/26/2013

Event Type  Injury  

Manufacturer Narrative

¿the reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.The reported device was manufactured and distributed by small bone innovation, inc., (b)(4) and implanted before stryker became the legal manufacturer.On april 1, 2015 stryker became the legal manufacturer of the star system and has taken the responsibility for the medical device reporting.¿ device disposition is unknown.

Event Description

The manufacturer became aware of a literature published by (b)(6).The title of this report is ¿comparison of the short-term results of first and last 50 scandinavian total ankle replacements: assessment of the learning curve in consecutive series¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.Article can be found on https://journals.Sagepub.Com/doi/full/10.1177/1071100713518187.Within that publication which included 100 patients, post-operative complications were reported, which allegedly occurred between may 1999 to may 2008.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses (2) cases of septic loosening followed by removal of star.The report states: ¿ three cases (6%) underwent an arthrodesis after failure of the star prosthesis due to septic loosening (2x) or aseptic loosening (1x).¿.

• Brand Name: UNKNOWN STAR TIBIAL COMPONENT
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10350198
• MDR Text Key: 203113629
• Report Number: 0008031020-2020-02046
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2020

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention