MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 11X142MM 2MM T1; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Hematoma (1884)

Event Date 06/01/2022

Event Type  Injury  

Event Description

It was reported the patient had a right total hip arthroplasty.Subsequently, patient underwent a revision approximately one (1) week later due to a displaced periprosthetic femur fracture.The fracture was reduced and stabilized.Femoral head and stem were exchanged without complication.No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Concomitant medical products: ref (b)(4), lot 64904799, shell; ref (b)(4), lot j7214202, self tapping bone screw; ref (b)(4), lot 65335217, self tapping bone screw; ref (b)(4), lot 64875044, liner; ref (b)(4), lot 3093921, ceramic head; ref (b)(4), lot 3100260, taper sleeve.(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: orif femur fracture, shaft ¿ displaced, unstable.Femoral stem easily removed.Multiple subcutaneous hematomas evacuated upon entry of recent incision; not an unexpected finding with bone fractures and recent surgery.Cable was placed distal to fracture area to protect it from propagation.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.

• Brand Name: TPRLC 133 T1 PPS HO 11X142MM 2MM T1
• Type of Device: 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: 14855596
• MDR Text Key: 295066866
• Report Number: 0001825034-2022-01499
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 00880304489714
• UDI-Public: (01)00880304489714(17)320107(10)7164333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• 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: 51-104110
• Device Lot Number: 7164333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 78 KG