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

Catalog Number UNK_SEL

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

Patient Problems Ossification (1428); Injury (2348)

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 (b)(6).The title of this report is ¿a prospective study of four total ankle arthroplasty implants by non-designer investigators¿ which is associated with the stryker ¿star¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from november 2001 to august 2010.It was not possible to ascertain specific device/patient 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 54 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses ankle gutter or heterotopic ossification debridement without metal component exchange with or without intact polyethylene exchange.5 out of 5 cases.

Manufacturer Narrative

Additional information in section h6 (patient code).

Event Description

The manufacturer became aware of a literature from (b)(6) hospital, canada.The title of this report is ¿a prospective study of four total ankle arthroplasty implants by non-designer investigators¿ which is associated with the stryker ¿star¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from (b)(6) 2001 to (b)(6) 2010.It was not possible to ascertain specific device/patient 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 (b)(4) complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses ankle gutter or heterotopic ossification debridement without metal component exchange with or without intact polyethylene exchange.(b)(4) out of (b)(4) cases.

• Brand Name: UNKNOWN TIBIAL COMPONENT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9861464
• MDR Text Key: 191723037
• Report Number: 0008031020-2020-00758
• Device Sequence Number: 1
• Product Code: HSB
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention