MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO B-MTRC MP FP SO 13; PROSTHESIS, HIP

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Unstable (1667)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 09/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000663 ¿ g7 shell ¿ 6549351, 010000857 ¿ g7 liner ¿ 6487188, 12115121 ¿ femoral head ¿ 2971324.Customer has indicated that the product will not be returned to zimmer biomet as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a right hip revision following a ground level fall and sustaining a periprosthetic fracture.During the procedure, the shell was left intact and the head, liner and stem components were removed and replaced without complications.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 noting patient experienced a ground level fall and a periprosthetic fracture leading to an unstable and loose hip prosthesis.The fracture was reduced and stabilized with a mini frag plate and cerclage cables.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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 additional event information to report at this time.

• Brand Name: ECHO B-MTRC MP FP SO 13
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9494579
• MDR Text Key: 173457550
• Report Number: 0001825034-2019-05624
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00880304697805
• UDI-Public: 00880304697805
• Combination Product (y/n): N
• PMA/PMN Number: K143009
• 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: 04/07/2020

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: 193013
• Device Lot Number: 744050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 121