MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 32MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 5572-4532

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fever (1858); Unspecified Infection (1930); Implant Pain (4561)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded.

Event Description

As reported: "subject, came in last week on (b)(6) complaining of pain and redness in the shoulder as well as a fever.After drawing a small amount of cloudy fluid, [surgeon] sent her immediately to the er and had her admitted for a debridement and washout.Site coordinator has not seen the results of the cultures yet, but signs point to infection per the operative report and clinic note.[surgeon] removed and exchanged all humeral components as well as the glenosphere.He left the original baseplate.He exchanged the old reunion components with other reunion components.".

• Brand Name: 4.5MM PERIPHERAL SCREW - 32MM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10701821
• MDR Text Key: 212084662
• Report Number: 0008031020-2020-02340
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327098754
• UDI-Public: 07613327098754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130895
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5572-4532
• Device Catalogue Number: 5572-4532
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2020
• 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
• Patient Age: 60 YR
• Patient Weight: 113