MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN TSA HUMERAL HEAD; IMPLANT

Catalog Number UNK_SEL

Device Problem Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturer became aware by an u.S.Publication "anatomic total shoulder arthroplasty using a self-pressurizing pegged bone preserving cemented glenoid component: a 2 to 5 year follow-up study¿, published in 2016 regarding the reunion total shoulder arthroplasty system (tsa), involving following implants: pegged glenoids, humeral heads and humeral stems.In sum 10 patients had been observed presenting 10 adverse events in a period from august 2011 to december 2014.It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database revealed that the events had not been reported by the hospital or by the author of the publication, therefore 6 complaints were initiated retrospectively.This product inquiry addresses a severe stiffness due to chondrolysis, which had been treated via arthroscopic contracture release in a revision surgery in conjunction to one tsa glenoid, one tsa humeral head and one tsa humeral stem.

• Brand Name: UNKNOWN TSA HUMERAL HEAD
• Type of Device: IMPLANT
• 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: 6440520
• MDR Text Key: 71102311
• Report Number: 0008031020-2017-00177
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• 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