MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO B-MTRC MP FP HO 9; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 010000663- g7 pps ltd acet shell 52e- 7123845, 20103605- g7 longevity neutral 36mm e- 65255946, 650-0661- delta ceramic fem hd 36/0mm- 3090519, 00625006530- bone screw self-tapping 6.5 mm dia.30 mm length- j7146594, 00625006520- bone screw self-tapping 6.5 mm dia.20 mm length- 65044174.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.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 during an initial procedure that a greater trochanteric fracture nondisplaced noted at time of surgery and on postoperative x-ray.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Reported event was confirmed via medical records reviewed by a health care professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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 information on the reported event.

• Brand Name: ECHO B-MTRC MP FP HO 9
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14015318
• Report Number: 0001825034-2022-00798
• Device Sequence Number: 6300934
• Product Code: LPH
• UDI-Device Identifier: 00880304697911
• UDI-Public: (01)00880304697911(17)280220(10)147800
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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: 193109
• Device Lot Number: 147800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American