MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC XR MP FP T1 PPS 4X93MM; 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	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a total hip arthroplasty.The surgeon indicated that it had been a difficult procedure.The broaching was challenging (woodpecker used), and distal canal reaming was required.A small femoral implant was used due to type a femur.Formus planning was utilized for this case.Approximately 2 months later, the patient fell while bushwalking, and presented in the emergency department with a periprosthetic of the left femur vancouver b (calcar split).The patient was then transported to a different facility and the hip was subsequently revised.The surgeon was happy with the final revision, and there were no surgical issues.No additional information.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat# 650-0663 lot# 2020021213 delta ceramic fem hd 36/+6mm.Cat# 110010243 lot# 7332485 g7 osseoti 3 hole shell 50mm d.Cat# 010000934 lot# 7057187 g7 hi-wall e1 liner 36mm d.Report source: foreign: country: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
No product was returned, or pictures provided; therefore, visual, and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were also reviewed for compatibility with no issues noted.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available x-ray records identified the following: overall fit and alignment, as well as bone quality appears normal.The angle measurements cannot be made on the provided image.There were no signs of loosening, wear, radiolucency, or other contributing factors.There was no clear indication if the size of the implant had caused the fracture.However, it was well noted that the intramedullary component of the left hip arthroplasty does not significantly extend into the subtrochanteric diaphysis.When compared to the right total hip arthroplasty, the intramedullary component is significantly smaller.A review of the available medical information identified the following: it was reported that the patient was "bushwalking" or hiking and fell.The patient exhibited a periprosthetic femur fracture, per the x-ray review, 5 weeks postoperatively.Within the first 6 weeks postoperatively, the goal is strengthening, walking without an assistive device, and balance training.In the following weeks, the focus is on endurance training, regaining full strength, and performing own adls.It is not recommended to go on a hike or bushwalking on uneven surfaces for the balance of the hip is not at 100%.Recommendations may vary individually by provider; however, typically this type of activity would not be recommended so early in the recovery.The reported issue was confirmed based on the provided medical records.The root cause of the reported issue is attributed to user error, as it is not recommended to walk on uneven surfaces for the balance of the hip is not at 100% within the first 6 weeks postoperatively.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: TPRLC XR MP FP T1 PPS 4X93MM
• 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: 16545051
• Report Number: 0001825034-2023-00452
• Device Sequence Number: 6490666
• Product Code: LPH
• UDI-Device Identifier: 00880304517417
• UDI-Public: (01)00880304517417(17)280213(10)6228185
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 07/06/2023

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: 51-149040
• Device Lot Number: 6228185
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2018
• 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: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male