MAUDE Adverse Event Report: STRYKER GMBH RFX HUMERAL STEM 8MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 5568-0008

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

Patient Problems Discomfort (2330); Implant Pain (4561)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3: other text : device remains implanted in patient.

Event Description

It was reported by the patient that they are experiencing soreness and pain.Additionally, the patient wants to know if their implants were part of any recall.

• Brand Name: RFX HUMERAL STEM 8MM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18969643
• MDR Text Key: 338501110
• Report Number: 0008031020-2024-00131
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 07613327172911
• UDI-Public: 07613327172911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5568-0008
• Device Lot Number: 183123-A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/25/2024
• 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): Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White