MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 36MM +3 HIWALL LINER SZ23; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09876, 0001825034 - 2018 - 09877, 0001825034 - 2018 - 09878.

Event Description

It was reported patient developed infection, causing incisional drainage 2 weeks post-operative initial hip procedure.Patient was treated with oral antibiotics.The drainage resolved and incision was well healed by 7 week follow up.No further treatment required.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.Reported event was confirmed by review of medical records received.Progress notes stated the patient developed infection, causing incisional drainage 2 weeks postoperatively.The patient was treated with oral antibiotics.Review of the device history record identified no deviations or anomalies that would contribute to reported event.A definitive root cause cannot be determined with the information provided.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: E-POLY 36MM +3 HIWALL LINER SZ23
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8001747
• MDR Text Key: 124888676
• Report Number: 0001825034-2018-09875
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• PMA/PMN Number: K090103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2021
• Device Model Number: N/A
• Device Catalogue Number: EP-108323
• Device Lot Number: 272260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN CUP; UNKNOWN HEAD; UNKNOWN STEM; UNKNOWN CUP; UNKNOWN HEAD; UNKNOWN STEM
• Patient Outcome(s): Required Intervention
• Patient Weight: 83