MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 NEUTRAL E1 LINER 36MM E; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Anemia (1706); Arrhythmia (1721); Fatigue (1849); Hypovolemia (2243); Blood Loss (2597)

Event Date 02/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000663-g7 pps ltd acet shell 52e-6578868, 192008-echo por fmrl nc 8x120mm-083280, 12-115120-cer bioloxd mod hd 36mm-2986013.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01069, 0001825034 - 2020 - 01073.The human body consists of 4-5 liters of blood.Any type of blood loss has the potential to cause a complication however; it is usually the large, rapid blood loss during surgery or a trauma that will most likely cause complications.The amount of blood loss that may lead to intra and/or postoperative complications depends on the individual person and comorbidities, such as body mass index, gender, low pre-operative hemoglobin levels, medications and/or the presence of certain health conditions such as anemia, hemophilia, etc., as well as duration of surgery.As blood loss effects are based on individual factors, treatment depends on the amount of blood loss, how quickly it was lost and the individuals health state.For larger blood loss, a blood transfusion or alternative may be needed.Hemorrhage is classified into 4 categories 1-4.Class i hemorrhage - minimal blood loss <750ml which would have minimal, if any impact on the patient, as the body will replenish a minimal blood loss without any intervention.Blood loss >750ml is considered to have larger impact and therefore the potential for medical intervention, i.E.Blood transfusion, or other alternative treatment.As the complaint indicates intraop blood loss greater than 750 ml, the patient had diagnosis of acute postop blood loss anemia and was symptomatic, medical intervention of blood transfusion (1 unit prbcs) was administered, and the patient's hospitalization was extended; therefore, complaint categories of medical: blood loss and medical: procedure related would be appropriate.Remains implanted.

Event Description

It was reported that a study patient had an initial left total hip arthroplasty that resulted with 800ml of blood loss.Subsequently, on postop day 1, the patient experienced tachycardia and fatigue that resulted in a blood transfusion and extended hospitalization.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

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

Event Description

It was reported that a study patient had an initial left total hip arthroplasty that resulted with 800ml of blood loss.Subsequently, on postop day 1, the patient experienced tachycardia and fatigue that resulted in a blood transfusion and extended hospitalization.At the 2 week follow up the patient states they are improving, ambulatory with 1 crutch, incision healing well, intact quad function and does have some weakness with hip flexion but is able to do so laying supine and raising leg.One moth postop follow up patient reports continued fatigue with difficulty sleeping at night but sleeping throughout the day, home medications adjusted, ambulatory with 1 crutch, no change or complications with her incision, patient tolerates gentle passive range of motion of left hip.Does have some noted and expected weakness with hip flexion.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: G7 NEUTRAL E1 LINER 36MM E
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9829254
• MDR Text Key: 189431785
• Report Number: 0001825034-2020-01072
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• 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: 010000857
• Device Lot Number: 6592218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 70