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

Catalog Number UNK_SEL

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

Patient Problem Injury (2348)

Event Date 10/10/2006

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 unknown.

Event Description

The manufacturer became aware of a literature published by falu hospital, in sweden.The title of this report is ¿secondary surgery after total ankle replacement: the influence of preoperative hindfoot alignment¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.The article can be found at https://www.Sciencedirect.Com/science/article/pii/s1268773106000919.Within that publication, post-operative complications/ adverse events were reported, which allegedly occurred from 1997 to 2004.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, 12 complaints were initiated retrospectively for the post-operative complications mentioned in the report.This product inquiry addresses impingement due to osseous overgrowth followed by revision including change of polyethylene component.The report states: ¿during the procedures the removal of impinging osseous overgrowth in the medial or lateral gutter was done including change of the polyethylene component to a higher one in seven ankles.¿.

• Brand Name: UNKNOWN STAR POLYETHYLENE INSERT
• 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: 10183332
• MDR Text Key: 198585235
• Report Number: 0008031020-2020-01725
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• 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: 05/26/2020
• 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