MAUDE Adverse Event Report: UNKNOWN PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Device Problem Nonstandard Device (1420)

Patient Problem Necrosis (1971)

Event Type  Injury  

Event Description

The patient reported they had two hip replacements that were metal on metal.Patient also reported that their hip replacements were recalled, and they had two revisions performed.Patient reported they also had necrosis.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17530193
• MDR Text Key: 321062813
• Report Number: MW5137113
• 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: 09/01/2015

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