MAUDE Adverse Event Report: STRYKER STRYKER CUP AND LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Device Problem Insufficient Information (3190)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/27/2016

Event Type  Injury  

Event Description

Clinical adverse event received for revision of left hip date of implantation: (all competitor products).Date of revision #1: (revision of competitor stem construct / head / and liner--no (left hip) (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STRYKER CUP AND LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER
• MDR Report Key: 17526628
• MDR Text Key: 321130588
• Report Number: MW5133567
• Device Sequence Number: 1
• Product Code: LPH
• 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: 01/14/2022

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