MAUDE Adverse Event Report: ZIMMER BIOMET PINNACLE PFS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/13/2021

Event Type  Injury  

Event Description

Pinnacle pfs alleges continue to have chronic pain in groin, hip, buttocks and back.Plaintiff had limited aol after first revision.Ppf and medical records have no information provided.Biomet cup, liner and bone screw were used with depuy head and stem.Original implant date (b)(6) 2016.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PINNACLE PFS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 17524045
• MDR Text Key: 321058752
• Report Number: MW5130991
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1