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

Catalog Number RHAS3

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

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

The reported event that a radial stem implant #3 (sterile packed) was alleged of poor fixation could be confirmed, thanks to the provided x-rays.This is the only complaint of this kind reported from 2009 to present.Based on investigation, the root cause was attributed to be user related.Too large reaming of the canal for the stem is the most likely cause of the event.Stryker¿s operative technique for the rhead system states that if a firm fixation is not present at the time of the insertion of the trial stem (i.E.Stem can be easily extracted from or rotated in the medullary canal), then bone cement (pmma) is recommended.Moreover, related stryker¿s ifu state that meticulous preparation of the implant site and selection of the proper size implant increase the potential for a successful outcome.It is the responsibility of the surgeon to be familiar with the procedure before use of this product.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

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 STEM 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: 6232632
• MDR Text Key: 64167113
• Report Number: 0008031020-2017-00015
• 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: RHAS3
• Device Lot Number: 24994801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2017
• 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