MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL NC 14X150MM; 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	08/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source australia.Customer has indicated that the product will not be returned to zimmer biomet for the investigation 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 patient underwent a right hip revision and placement of cables approximately 9 days post implantation due to periprosthetic fracture.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.The following sections were updated/corrected.Updated: d4; g3; h2; h4.
Event or Problem Description
No additional event information to report at this time.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) ¿ stem.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no signs of loosening, wear, radiolucency, or other contributing factors.Mildly displaced lesser trochanter periprosthetic fracture.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 related to the reported event.A definitive root cause cannot be determined.A summary of the investigation was requested and sent to the customer.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: ECHO POR FMRL NC 14X150MM
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15299846
• Report Number: 0001825034-2022-01954
• Device Sequence Number: 2407268
• Product Code: KWA
• UDI-Device Identifier: 00887868260452
• UDI-Public: (01)00887868260452(17)300725(10)874700
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2022

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: 192014
• Device Lot Number: 874700
• 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: 08/03/2022
• Supplement Date Received by Manufacturer: 09/19/2022; 10/14/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 10/13/2022; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2020
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK CUP; UNK HEAD; UNK LINER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male