MAUDE Adverse Event Report: STRYKER GMBH RADIAL HEAD IMPLANT #3 (STERILE PACKED); ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number RHAH3

Device Problems Loose or Intermittent Connection (1371); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2016: surgeon placed a radius head prosthesis - first time surgeon uses this product and declares "preoperatively i was satisfied with the performance, but i did have some doubts about the placement of the stem in the proximal radius.I missed the clamp feeling that i recognize from for example, the judet rhs of tornier in uncemented placement.X-ray shows loosening of the component.On (b)(6) 2016 conducted an screening to confirm loosening and then performed second surgery that same day.The component was completely loose and the prosthesis was placed again but now with bone cement.

Manufacturer Narrative

This device is concomitant and did not contribute to the reported failure.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

Event Description

On (b)(6) 2016: surgeon placed a radius head prosthesis - first time surgeon uses this product and declares "preoperatively i was satisfied with the performance, but i did have some doubts about the placement of the stem in the proximal radius.I missed the clamp feeling that i recognize from for example, the judet rhs of tornier in uncemented placement.X-ray shows loosening of the component.On (b)(6) 2016 conducted an screening to confirm loosening and then performed second surgery that same day.The component was completely loose and the prosthesis was placed again but now with bone cement.

• Brand Name: RADIAL HEAD IMPLANT #3 (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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6232630
• MDR Text Key: 64167652
• Report Number: 0008031020-2017-00016
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K002644
• 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: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RHAH3
• Device Lot Number: 24993401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• 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