MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN TALAR COMPONENT; IMPLANT

Catalog Number UNK_SEL

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

Patient Problems Tissue Damage (2104); Osteolysis (2377)

Event Date 11/01/2001

Event Type  Injury  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group.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 from st.Michael¿s hospital, canada.The title of this report is ¿intermediate to long-term outcomes of total ankle replacement with the scandinavian total ankle replacement (star)¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from november 2001 to october 2005.It was not possible to ascertain specific device details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 64 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses lytic lesions of talus and fibula.

Event Description

The manufacturer became aware of a literature from (b)(6) canada.The title of this report is ¿intermediate to long-term outcomes of total ankle replacement with the scandinavian total ankle replacement (star)¿ which is associated with the stryker ¿scandinavian total ankle replacement (star)¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from (b)(6) 2001 to (b)(6) 2005.It was not possible to ascertain specific device details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 64 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses lytic lesions of talus and fibula.

Manufacturer Narrative

New information in section h6 (patient code).

• Brand Name: UNKNOWN TALAR COMPONENT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9776195
• MDR Text Key: 190924896
• Report Number: 0008031020-2020-00541
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• 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: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR