MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 VIVACIT-E 36MM I.D. SIZE F NEUTRAL LINER; 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  

Manufacturer Narrative

(b)(4).D10: cat# 650-0662, delta ceramic fem hd 36/+3mm.Cat# 010000664, lot# 7045233, g7 pps ltd acet shell 54f.Cat# 51-104110, tprlc 133 t1 pps ho 11x142mm.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.

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

This follow-up report is being submitted to relay additional information.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Additional information received.It was reported that the patient also experienced muscle atrophy, effusion, stiffness, abnormal gait, decreased rom with severe femoral internal rotation, popping sensation with grinding, and decreased stability that required extra physical therapy.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left total hip arthroscopy was performed approximately three years ago with no complications noted.Approximately two months post implantation of the left total hip arthroplasty, the patient began reporting instability, difficulty ambulating, stiffness, and pain.The patient started physical therapy and noted some improvements; however, still had pain and additional symptoms.The lab test for titanium came back negative.A revision has not yet occurred.The reported issue was confirmed based on the provided medical records.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: G7 VIVACIT-E 36MM I.D. SIZE F NEUTRAL LINER
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18721095
• MDR Text Key: 335581465
• Report Number: 0001822565-2024-00509
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190660
• 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,Followup
• Report Date: 05/15/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 30103606
• Device Lot Number: 65099805
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 02/26/2024; 05/14/2024
• Supplement Dates FDA Received: 03/04/2024; 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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