MAUDE Adverse Event Report: STRYKER GMBH HUMERAL CUP - 32MM DIA X 10MM THK; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5570-3210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Fever (1858); Unspecified Infection (1930); Implant Pain (4561)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded.
Event or Problem Description
As reported: "subject, came in last week on 9/17 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: HUMERAL CUP - 32MM DIA X 10MM THK
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10701741
• Report Number: 0008031020-2020-02333
• Device Sequence Number: 3259384
• Product Code: KWS
• UDI-Device Identifier: 07613327098358
• UDI-Public: 07613327098358
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 5570-3210
• Device Catalogue Number: 5570-3210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 113