MAUDE Adverse Event Report: STRYKER STRYKER STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

On sept 21, 2020 a complaint was received directly from the patient via e-mail to reception (the complaint is received by bq responsible person on sept 22, 2020): "on (b)(6) 2020 i had a paid surgical operation by implanting stem synthes.After 3 months, it broke in operated shinbone (tibia).At the same time, i followed all doctor's prescriptions.As the result the bone broke again.I had to tum for a second paid surgical operation for repeated osteosynthesis.I would like to discuss on this matter with a representative of your company.Preferably in russian.I ask for your assistance.I will provide all necessary documents upon request.The photos are attached".The device is available for investigation.Please note: during investigation non-destructive methods must be applied.We are awaiting that patient will plan to perform additional investigation at a local laboratory as a part court investigation.On 24 sept 2020 patient provided more information to (b)(6) as response to email from russian office jnj to collect event information.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STRYKER STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER
• MDR Report Key: 17530778
• MDR Text Key: 321109664
• Report Number: MW5137696
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1