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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 07/27/2018

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 was requested but not returned by the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item # 51-100070, stem, lot # 3373103.Item # 11-363661, head, lot # 494290.Item # cp156352, liner, lot # 719480.Item # 103533, bone screw, lot # 568340.

Event Description

It was reported that a patient underwent a revision surgery approximately 3.5 years post implantation due to liner fracture.Attempts have been made, and no further information has been provided.

Event Description

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

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

• Brand Name: E-POLY 36MM +3 MAXROM LNR SZ23
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7800693
• MDR Text Key: 117705745
• Report Number: 0001825034-2018-08318
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• PMA/PMN Number: PK090103
• 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: 01/14/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: EP-108223
• Device Lot Number: 864570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention