MAUDE Adverse Event Report: STRYKER JOINT CONSTRUCTION; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Device Problems Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problem Osteolysis (2377)

Event Date 06/21/2021

Event Type  Injury  

Event Description

It was reported that the patient was diagnosed as having poly wear and osteolysis around the cup.The surgeon said the patient had their hip done roughly 20+ years prior.He was unsure of the exact date.He told me that it was done at (b)(6) by dr.(b)(6).The surgeon decided the patient would benefit from a revision of their acetabular components.The stem was an srom, and the surgeon removed it in order to gain better exposure to the acetabulum.Once the femoral head and stem were removed, dr.(b)(6)removed the cup, which ended up being a competitor acetabular component.The liner was in fact pretty worn out and needed to be revised.Original implant date 2000.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: JOINT CONSTRUCTION
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): STRYKER
• MDR Report Key: 17532384
• MDR Text Key: 321135904
• Report Number: MW5139292
• Device Sequence Number: 1
• Product Code: KWA
• 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: 07/07/2021

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