MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 PPS LTD ACET SHELL 50D; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 30103604- g7 vit e neutral lnr 36mm d- 64797263.00877503602- bioloxâ® delta, ceramic femoral head, m, 㸠36/0, taper 12/14- 2993410.0106010003- avenirâ® mã¼ller, stem, standard, uncemented, ha, 3, taper 12/14- 2966718.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Facilities have discharge criteria that patients must meet post-surgical procedure.If the discharge criteria are not met, then the patient will be kept until they are stable for discharge, and for their safety.The delayed/prolonged hospitalization is not abnormal, as side effects from anesthesia are common and typically resolve within 24-48 hours.Anemia is a condition that develops when your blood is deficient in red blood cells (hemoglobin), which limits the hemoglobin's ability to carry enough oxygen throughout the body's system.With the lack of oxygen, the patient can experience, light headedness, weakness, fatigue, fainting, dizziness, elevated heart rate.Anemia can be associated with different medical conditions or can be directly related to blood loss during a trauma, surgical procedure or surgical complication.Anemia depending on the cause can be monitored and treated minimally or if hemoglobin is significantly low, it could be indicated that medical intervention is necessary to treat, i.E.Administering blood or other medical interventions.As postoperative development of anemia develops with no other identified cause, this signifies a postoperative procedure-related complication.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.

Event Description

It was reported patient experienced post-operative anemia and hypotension requiring medical intervention and prolonged hospitalization 2 days¿ post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: G7 PPS LTD ACET SHELL 50D
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10763581
• MDR Text Key: 213915213
• Report Number: 0001825034-2020-03968
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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: 010000662
• Device Lot Number: 6727744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 75