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

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Unstable (1667)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	09/29/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
No additional event information to report at this time.

• Brand Name: ECHO B-MTRC MP FP SO 13
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9494579
• Report Number: 0001825034-2019-05624
• Device Sequence Number: 13916836
• Product Code: LPH
• UDI-Device Identifier: 00880304697805
• UDI-Public: 00880304697805
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K143009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 121