MAUDE Adverse Event Report: STRYKER GMBH LAT ASSEMBLY, RAD STEM HEAD IMPLANT, SIZE 4; ELBOW JOINT RADIAL (HEMI-ELBOW) POLYMER PROSTHESIS

Catalog Number 3100010

Device Problems Delamination (2904); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device will not be available to stryker.

Event Description

It was reported via fda report no.Mw5065989 pt.With multiple revision surgery on left elbow had a stryker lateral radial head size 4 prosthestis placed during last revision.Current revision of left radial head arthroplasty noted device failure with delamination of the head from the stem and failure of the taper lock (part of middle locking mechanism actually disengaged).

Manufacturer Narrative

The reported event that a lat assembly, rad stem head implant, size 4 delaminated from the stem after surgery could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to be user related.Please note that it is the responsibility of the surgeon to be familiar with the procedure before use of these products.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported via fda report no.Mw5065989 pt.With multiple revision surgery on left elbow had a stryker lateral radial head size 4 prosthestis placed during last revision.Current revision of left radial head arthroplasty noted device failure with delamination of the head from the stem and failure of the taper lock (part of middle locking mechanism actually disengaged).

• Brand Name: LAT ASSEMBLY, RAD STEM HEAD IMPLANT, SIZE 4
• 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: 6225113
• MDR Text Key: 63949177
• Report Number: 0008031020-2017-00002
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 3100010
• Device Lot Number: 10162-107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2015
• 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