MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR FMRL 17.5X155; PROSTHETIC, HIP

Model Number N/A

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 04/26/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 157448, m2a-magnum mod hd sz 48mm , 364970.157854 , m2a-magnum recap cup 54odx48id, 967970.139252 , m2a-magnum 42-50mm tpr insrt-6 , 516950.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 00968.0001825034 - 2023 - 00970.0001825034 - 2023 - 00971.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted h3 other text : device location is unknown.

Event Description

It was reported that the patient underwent a revision procedure approximately 15 years post implantation due to pain.The hip pain had been around for a little while but had been getting worse, prompting the patient to have it checked.There is no additional information available at the time of this report.

Event Description

No further information at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Mechanical (g04) ¿ stem.Visual examination of the provided pictures identified a cup, head, stem on the table, no other observations could be made from the image.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues: left total hip arthroplasty with undersized acetabular component.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that the patient underwent a revision procedure 14 years and 11 months post implantation due to pain and elevated metal ion levels.Intraoperatively, metal related pathology was noted and the acetabular component was found to be malpositioned, although well fixed.A proximal femur fracture occurred following difficulty removing the femoral component which required plating to repair.All components were ultimately successfully exchanged with no other known complication.There is no additional information available at the time of this report.

• Brand Name: TAPERLOC POR FMRL 17.5X155
• Type of Device: PROSTHETIC, 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: 16868232
• MDR Text Key: 314552667
• Report Number: 0001825034-2023-00972
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 103209
• Device Lot Number: 401760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 09/06/2023; 02/15/2024
• Supplement Dates FDA Received: 09/08/2023; 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PLEASE SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 118 KG