MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH UNKNOWN_SELZACH_PRODUCT; IMPLANT

Catalog Number UNK_SEL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 03/13/2015

Event Type  Injury  

Event Description

Patient needed a revision from a star ankle implanted in 1999.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.Unknown star poly.

Manufacturer Narrative

(b)(4).

Event Description

Patient needed a revision from a star ankle implanted in 1999.

• Brand Name: UNKNOWN_SELZACH_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4672783
• MDR Text Key: 5619410
• Report Number: 0008031020-2015-00138
• Device Sequence Number: 1
• Product Code: NTG
• 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,Followup
• Report Date: 03/13/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 04/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 59 YR