MAUDE Adverse Event Report: STRYKER GMBH (MDR) UNKNOWN_SELZACH_PRODUCT; IMPLANT

Catalog Number UNK_SEL

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 05/05/2015

Event Type  Injury  

Event Description

It was reported that a revision of a star total ankle has been scheduled for soft tissue replacement.Routine polyethylene exchange is anticipated.

Manufacturer Narrative

The reported device was manufactured and distributed by small bone innovation, inc., (b)(4) 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.Unknown star polyethylene.Once the investigation has been completed any additional information will be reported in a supplemental report.

Manufacturer Narrative

Please note corrections: evaluation summary: according to information provided by stryker sales rep.The surgery had been rescheduled for (b)(6).Further information is expected to become available then.At the moment a revision surgery for soft tissue replacement is announced and a causal connection with the subject device ¿star polyethylene¿ is unclear.Furthermore a routine polyethylene exchange is anticipated but not actually scheduled.With respect to very sparse information a thorough investigation is not possible at the moment.The investigation thus will be closed formally and can be reopened as soon as further information is available.

Event Description

It was reported that a revision of a star total ankle has been scheduled for soft tissue replacement.Routine polyethylene exchange is anticipated.

• Brand Name: UNKNOWN_SELZACH_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH (MDR); bohnackerweg 1; postfach; selzach 02545 ; SZ 02545
• Manufacturer (Section G): STRYKER GMBH (MDR); bohnackerweg 1; postfach; selzach 02545 ; SZ 02545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4814380
• MDR Text Key: 5892486
• Report Number: 0008031020-2015-00221
• Device Sequence Number: 1
• Product Code: HTY
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2015

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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