MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DEPUY PINNACLE SHELL SIZE 52 AND A +4 10-DEGREE LINER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Device Problems Defective Component (2292); Noise, Audible (3273)

Patient Problem Failure of Implant (1924)

Event Date 05/22/2023

Event Type  Injury  

Event Description

Possible defective hip replacement implants installed into my right hip during (b)(6) 2021; manufacturer was depuy synthes and summit.The implant in question is provided as follows: depuy pinnacle shell size 52 and a +4 10-degree liner; additional implant materials used in my hip are: summit femoral stem size 4, standard offset and femoral head is a +1.5 32mm ceramic.I felt and heard a buckling loud pop sound come from my hip during a normal leisurely walk on monday (b)(6) 2023.Since that date, there are continuous squeaky noises coming from my hip and femur.Two medical doctor opinions have been obtained since (b)(6) 2023 and both doctors have told me that i would need a 'hip revision implant' operation to correct this problem.The squeaking noises are evident and continuous in my right hip/groin area and femoral areas.Reference reports: mw5118043, mw5118044.

Event Description

Additional information received on 06/22/2023 from reporter for mw5118042.After (b)(6) 2023, i processed a customer complaint to depuy synthes at the time of the collapse of the mentioned right hip implant of (b)(6) 2021.A depuy synthes customer quality department employee by the name of (b)(4) has advised me via email that depuy synthes is in the process of requesting that an investigation be conducted.Specifics about the investigation were not provided to me.Reference report: mw5118043, mw5118044.

• Brand Name: DEPUY PINNACLE SHELL SIZE 52 AND A +4 10-DEGREE LINER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 17050098
• MDR Text Key: 316502837
• Report Number: MW5118042
• 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,Followup
• Report Date: 05/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ALLEGRA; BREO ELLIPTA INHALER; CENTRUM SILVER; COLESTIPOL, I DON'T USE MEDICAL DEVICES.; CRANBERRY SUPPLEMENT; LUTEIN SUPPLEMENT; TUMERIC SUPPLEMENT
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White