MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER AND SHELL WITH PLASTIC BARRIER 44 MM I.D. 56 MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 10/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01075.

Event Description

It was reported the patient developed an infection shortly after post implantation, which required a washout and antibiotic therapy.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed with medical records and radiographs provided.Review of the available medical records identified the patient developed an infection and underwent a wound washout with antibiotic therapy.Patient visited the surgeon again as he development superficial infection that was leaking serous fluid.The culture came back positive.The patient had seropurulent discharge with surrounding erythema.Cultures determined that there was no deep infection.Review of radiographs identified no issues that could contribute to the reported event.Review of the device history records identified no related deviations or anomalies during manufacturing.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.

Event Description

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

• Brand Name: LINER AND SHELL WITH PLASTIC BARRIER 44 MM I.D. 56 MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8416226
• MDR Text Key: 138651695
• Report Number: 0001822565-2019-01074
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

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: 00151505644
• Device Lot Number: 62910283
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2019
• Initial Date FDA Received: 03/13/2019
• Supplement Dates Manufacturer Received: 08/08/2019
• Supplement Dates FDA Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ZIMMER HEAD, CATALOG#00877704401, LOT#2806923; ZIMMER STEM, CATALOG#65771100920, LOT#62831841; ZIMMER HEAD, CATALOG#00877704401, LOT#2806923; ZIMMER STEM, CATALOG#65771100920, LOT#62831841
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 109