MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. LEFT HIP REPLACEMENT; METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED

Lot Number M26R7

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Depression (2361); Numbness (2415)

Event Date 02/27/2023

Event Type  Injury  

Event Description

Patient called to report that approximately thirty days post surgery (left hip replacement), she experienced a hip dislocation (b)(6) 2023 despite following protocol for recovery.She was hospitalized and administered morphine for excruciating pain and numbness and was not able to walk for a while (non-weight bearing).On (b)(6) 2023 she experienced another hip dislocation (same side) and was taken to the hospital by fire and rescue and subsequently had surgical intervention to relocate the prosthetic hip.On (b)(6) 2023, she had additional surgery for the implant liner to be replaced as well as placing a larger cup to accommodate the liner and has been confined to her bed.Patient states that she still has "stabbing pain" in her hip and cannot walk without her cane when standing.She is still recovering from these events.This experience has forced her to retire from work and has caused her to have depression.

• Brand Name: LEFT HIP REPLACEMENT
• Type of Device: METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 16919868
• MDR Text Key: 315234930
• Report Number: MW5117500
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: M26R7
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female