MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 54F; PROTHESIS, HIP

Model Number N/A

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

Patient Problems Inflammation (1932); Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032); Hot Flashes/Flushes (2153); Ambulation Difficulties (2544); Cognitive Changes (2551); Syncope/Fainting (4411); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported that the patient had a left total hip arthroplasty approximately 1.5 years ago.Right after surgery, the patient reportedly experienced cognitive decline and constant syncope with the feeling that something felt off and weird.Since surgery, the patient is having a constant burning pain, warmth to thigh, and a hot spot to bursa area.Additionally, the patient is experiencing difficulty with ambulation, and went from a cane to a walker, and now a wheelchair.The patient also reported inflammation in the body and the development of degenerative disc disease since surgery.The patient has been treated with pain medication and nerve ablation.It was reported that the patient will have metal allergy testing completed in the near future.No additional information available.

Manufacturer Narrative

(b)(4).D10: cat# 650-0662, delta ceramic fem hd 36/+3mm.Cat# 51-104110, tprlc 133 t1 pps ho 11x142mm.Cat# 30103606, 36mm i.D.Size f neutral liner.Product remains implanted and will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2024-00408.

• Brand Name: G7 PPS LTD ACET SHELL 54F
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18721073
• MDR Text Key: 335581282
• Report Number: 0001825034-2024-00407
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 010000664
• Device Lot Number: 7045233
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White