MAUDE Adverse Event Report: J&J DEPUY J&J DEPUY ORTHOPEDICS HIP REPLACEMENT; ACETABULAR CUP

Catalog Number 132-28-25

Device Problems Material Discolored (1170); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Pain (1994); Perforation (2001); Osteolysis (2377)

Event Date 12/01/2015

Event Type  Injury  

Event Description

Patient presented with c/o left hip pain on (b)(6) 2001, had total hip replacement 2009.X-ray did show eccentric wear of components.Decision was made to do revision.During surgery, discoloration of acetabular liner consistent with possible oxidation was noted.Surgeon felt well on way to catastrophic failure of the acetabular liner.Gross osteolysis was noted behind the cup and the posterior wall was essentially a shell of bone and was actually perforated.

• Brand Name: J&J DEPUY ORTHOPEDICS HIP REPLACEMENT
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): J&J DEPUY
• MDR Report Key: 5612138
• MDR Text Key: 43878075
• Report Number: MW5061899
• Device Sequence Number: 1
• Product Code: JDG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/22/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 132-28-25
• Device Lot Number: 120-01-46
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR