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

Catalog Number UNK_SEL

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

Patient Problems Pain (1994); Injury (2348); Non-union Bone Fracture (2369)

Event Date 02/01/2008

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 ¿short-term results of our first 49 scandanavian total ankle replacements (star)¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.Article can be found on https://journals.Sagepub.Com/doi/10.3113/fai.2008.0124.Within that publication which included 47 patients, post-operative complications were reported, which allegedly occurred between may 1999 to june 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, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses persistant pain due to non-union and impingement followed by second operative procedure.The report states: ¿two other patients complaining of persistent pain underwent a second operative procedure.In one, a cyst in the medial malleolus was filled with cancellous bone.In the other a non-union of a fibula fracture and an anterior impingement due to fibrosis in the lateral gutter were treated.".

Event Description

The manufacturer became aware of a literature published by sint maartenskliniek, in netherlands.The title of this report is ¿short-term results of our first 49 scandanavian total ankle replacements (star)¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.Article can be found on https://journals.Sagepub.Com/doi/10.3113/fai.2008.0124.Within that publication which included 47 patients, post-operative complications were reported, which allegedly occurred between may 1999 to june 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, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses persistant pain due to non-union and impingement followed by second operative procedure.The report states: ¿ two other patients complaining of persistent pain underwent a second operative procedure.In one, a cyst in the medial malleolus was filled with cancellous bone.In the other a non-union of a fibula fracture and an anterior impingement due to fibrosis in the lateral gutter were treated.¿.

Manufacturer Narrative

Correction: refer to h6 health impact code.

• Brand Name: UNKNOWN STAR TIBIAL COMPONENT
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10389952
• MDR Text Key: 203122707
• Report Number: 0008031020-2020-02138
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• 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
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention