MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, ø 36/+7, TAPER 12/14; HIP IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Low Blood Pressure/ Hypotension (1914)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: g7 pps ltd acet shell 58g item #010000666 lot# 6911164 36mm i.D.Size g neutral liner item # 30103607 lot #64986276 femoral stem cementless collared high offset 12/14 taper size 5 item # 574202050 lot# 3050331 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent an initial right total hip arthroplasty.Subsequently, prior to outpatient discharge, post-operative orthostatic hypotension and a right posterolateral hematoma were noted.The patient was transferred from the surgery center and admitted to a hospital facility for observation and medical intervention.Symptoms resolved and the patient was discharged two days later.The study has since been completed per protocol with no further complications or allegations against the device, all initial product remains implanted.Due diligence is in progress for this complaint; to date no additional information has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure or trauma and can predispose the patient to infection.The development of a postoperative hematoma can be correlated with the surgical procedure and perioperative anticoagulation therapy prescribed to prevent thrombus formation.Most hematomas resolve on their own, without surgical intervention, while some do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.Low blood pressure occurs when blood pressure is much lower than normal.This means the heart, brain, and other parts of the body may not get enough blood.Normal blood pressure is mostly between 90/60 mmhg and 120/80 mmhg.The medical word for low blood pressure is hypotension.Low blood pressure is only a problem if it has a negative impact on the body and produces symptoms.Some causes of hypotension include blood loss, dehydration and certain medications, such as pain or antihypertensive drugs.The most common symptom of orthostatic hypotension is lightheadedness or dizziness when standing after sitting or lying down.Symptoms usually last less than a few minutes.Orthostatic hypotension can have causes that aren't due to underlying disease.Examples include dehydration, standing up too quickly, medication side effects, or aging.Treatment depends on the cause.For example, the dosages of existing medications may need to be altered or a bleeding stomach ulcer surgically repaired.If no particular cause can be found, drugs may be used to raise blood pressure.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional information at this time.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, XL, ø 36/+7, TAPER 12/14
• Common Device Name: HIP IMPLANT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18928621
• Report Number: 0009613350-2024-00109
• Device Sequence Number: 4449854
• Product Code: LZO
• UDI-Device Identifier: 00889024430389
• UDI-Public: (01)00889024430389(17)300930(10)3044037
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00877503604
• Device Lot Number: 3044037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: White