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

Catalog Number UNK_SEL

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

Patient Problems Injury (2348); Deformity/ Disfigurement (2360)

Event Date 07/01/2011

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) bone and joint specialist, in usa.The title of this report is ¿correction of moderate to severe coronal plane deformity with the star¿ ankle prosthesis¿ which is associated with the stryker ¿star¿ ankle¿ system.The article can be found at https://doi.Org/10.3113%2ffai.2011.0659.Within that publication which included 130 patients, post-operative complications were reported, which allegedly occurred from january 2000 to december 2009.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 valgus hindfoot deformity which required calcaneal osteotomy.The report states: "one patient had a medial displacement calcaneal osteotomy for progressive valgus hindfoot deformity 6 years following the index procedure, which corrected the problem.¿.

Manufacturer Narrative

Refer to h6 clinical and health impact codes.

Event Description

The manufacturer became aware of a literature published by oakland bone and joint specialist, in usa.The title of this report is ¿correction of moderate to severe coronal plane deformity with the star¿ ankle prosthesis¿ which is associated with the stryker ¿star¿ ankle¿ system.The article can be found at https://doi.Org/10.3113%2ffai.2011.0659.Within that publication which included (b)(4) patients, post-operative complications were reported, which allegedly occurred from (b)(6)20000 to (b)(6)2009.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 valgus hindfoot deformity which required calcaneal osteotomy.The report states: "one patient had a medial displacement calcaneal osteotomy for progressive valgus hindfoot deformity 6 years following the index procedure, which corrected the problem.¿.

• Brand Name: UNKNOWN STAR TALAR COMPONENT
• Type of Device: PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10363092
• MDR Text Key: 203176952
• Report Number: 0008031020-2020-02061
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• 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: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention