MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. PINNACLE ALTRX; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 122136454

Device Problem Defective Component (2292)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/07/2022

Event Type  malfunction  

Event Description

After my left hip replacement, i started to set off theft alarms in the stores.These devices search for radio frequencies, not metal.I contacted the company to complain, and at first, they offered me a new hip to replace the defective equipment.Then they said they wanted to give me a settlement.Then they refused to do either.They know the equipment is defective but won't stand by their product.I tried to see if the product had a recall on it but could not discern if it did.I would like to know if i have defective equipment in me or not.I would also like to keep this from happening to other people.My doctor laughed when i told him about this but it is not funny.I got no help from either the doctor or the manufacturer.Please investigate to see why this product is defective.

• Brand Name: PINNACLE ALTRX
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 16215224
• MDR Text Key: 307982851
• Report Number: MW5114399
• Device Sequence Number: 2
• 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: 01/17/2023
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 122136454
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Race: White