MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN REUNION GLENOSPHERE; IMPLANT

Catalog Number UNK_SEL

Device Problems Loose or Intermittent Connection (1371); Metal Shedding Debris (1804); Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported: "i recently revised a case with local la surgeon where the base plate was locked about 1 cm lateral to the glenoid.The glenosphere may have been inadequately seated as well.The patient had tremendous pain from day one and upon revision surgery had significant metallosis in the tissues, a loose glenosphere, and an 'airball' base plate".

• Brand Name: UNKNOWN REUNION GLENOSPHERE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7371834
• MDR Text Key: 103516794
• Report Number: 0008031020-2018-00220
• Device Sequence Number: 1
• Product Code: KWS
• 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
• Report Date: 03/26/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/26/2018
• 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