MAUDE Adverse Event Report: STRYKER GMBH #2 BIPOLAR RADIAL HEAD IMPLANT (STERILE PACKED); ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number RCNH2

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 06/06/2014

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.(b)(4).Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

Revision surgery due to surgeon implanting metal head with metal stem.Exchanged metal head with a poly head.

• Brand Name: #2 BIPOLAR RADIAL HEAD IMPLANT (STERILE PACKED)
• Type of Device: ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5316962
• MDR Text Key: 34072092
• Report Number: 0008031020-2015-00573
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K023604
• 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: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RCNH2
• Device Lot Number: 23826901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2014
• 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