MAUDE Adverse Event Report: STRYKER GMBH REVISION SLIDING CORE STAR ANKLE 12MM; IMPLANT

Catalog Number 99002812F

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 07/25/2014

Event Type  Injury  

Manufacturer Narrative

With guidance from the mdr policy branch of the fda, mdr reported by stryker (b)(4) as a result of a retrospective lookback of complaints resulting from the acquisition of assets from small bone innovation, inc.The reported device was manufactured and distributed by small bone innovation, inc., (b)(6) and implanted prior to howmedica osteonics corp.¿s purchase of certain assets of sbi on (b)(6) 2014.  stryker became legal manufacturer of this product on (b)(6) 2015 and has taken the responsibility for medical device reporting.Device will not be returned.  if additional information becomes available it will be provided on a supplemental report.The device is not available to stryker.

Event Description

Revision surgery.Ligament instability.

• Brand Name: REVISION SLIDING CORE STAR ANKLE 12MM
• Type of Device: IMPLANT
• 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: 5331660
• MDR Text Key: 34564798
• Report Number: 0008031020-2015-00755
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/25/2014

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 Expiration Date: 09/30/2017
• Device Catalogue Number: 99002812F
• Device Lot Number: 1236067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2014
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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