MAUDE Adverse Event Report: ZIMMER BIOMET PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Device Problems Material Fragmentation (1261); Patient-Device Incompatibility (2682)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

The patient reported they had a left hip revision.Following the revision, it was determined that the patient's left hip pain was caused by a defective implant that caused their hip socket to fill 70% with abnormal bone growth and metal fragments, which gave them toxic levels of cobalt and chromium in their blood.(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/POLYMER, CEMENTED
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 17532056
• MDR Text Key: 321132120
• Report Number: MW5138966
• 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: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1