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

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Post Operative Wound Infection (2446)

Event Date 02/24/2010

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 (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 coxa hospital for joint replacement, in finland.The title of this report is ¿total ankle replacement: a population-based study of 515 cases from the finnish arthroplasty register¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.Article can be found on https://doi.Org/10.3109/17453671003685459.Within that publication which included 217 cases, post-operative complications were reported, which allegedly occurred between 1997 to 2006.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 3 cases of infection followed by revision.

• Brand Name: UNKNOWN STAR MENISCAL IMPLANT
• 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: 10319280
• MDR Text Key: 200214211
• Report Number: 0008031020-2020-01954
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• 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
• Date Manufacturer Received: 06/30/2020
• 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