MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SROM MODULAR STEM WITH PINNACLE ACETABULAR CUP, CERAMIC HEAD, POLYETHYLENE LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 03/15/2024

Event Type  Injury  

Event Description

Revised total hip arthroplasty due to painful loosening.Discovered evidence of metallosis.Depuy srom stem ceramic cup, polyethylene liner, pinnacle acetabular cup.Failed tha only 3.5 years old due to metallosis.

• Brand Name: SROM MODULAR STEM WITH PINNACLE ACETABULAR CUP, CERAMIC HEAD, POLYETHYLENE LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 18949457
• MDR Text Key: 338347698
• Report Number: MW5153031
• Device Sequence Number: 1
• Product Code: LPH
• 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: 03/18/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2024
• Patient Sequence Number: 1
• Treatment: ALLEGRA; BENADRYL ; EZETIMIBE ; PLAQUENIL ; TYLENOL ; WELLBUTRIN
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White