MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET UNKNOWN E1 MAXROM LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 04/16/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional concomitant medical products: item # 51-107150, stem, lot # unk; item # 650-1057, head, lot # unk; item # unk, shell, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 05748, 0001825034 - 2018 - 05749, 0001825034 - 2018 - 05750.

Event Description

It was reported that approximately 1 week post implantation, the patient reported to the er with concern for infection due to posterior thigh pinkness and pruritis.Patient was given iv antibiotics, and then placed on oral antibiotics with discontinuation of ecotrin.Patient was found to have a dvt, which was treated with arixtra.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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.Concomitant medical products: (b)(4), stem, lot # unk; (b)(4), taper, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-09375.

• Brand Name: BIOMET UNKNOWN E1 MAXROM LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7767107
• MDR Text Key: 116550903
• Report Number: 0001825034-2018-05751
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 73