MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK CUP; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

It was reported one patient developed postoperative deep vein thrombosis (dvt) in the popliteal vein and underwent successful therapeutic anticoagulation.No additional information.Doi: 10.1302/0301-620x.103b7.Bjj-2020-2382.R1.

Manufacturer Narrative

(b)(4).Source foreign: country: canada.Literature: review of complications, functional outcome, and long-term survival following conversion of hip fusion to total hip arthroplasty.C.I.Ayekoloye, m.Abu qaoud, m.Radi, s.A.Leon, p.Kuzyk, o.Safir, a.E.Gross.The bone and joint journal.Doi:10.1302/0301-620x.103b7.Bjj-2020-2382.R1.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02128, 0001822565-2022-02129 and 0001822565-2022-02130.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Deep vein thrombosis, or dvt, occurs when a blood clot forms in one of the deep veins of the body.This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops.Total joint patients are typically placed on medication post-operative for a period of time to prevent the development of dvt/blood clot.Even with the administration of preventive medication, dvt/blood clots can still develop.As the complaint indicated, a post-operative complication developed and medical intervention was required to treat the complication.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.Upon reassessment of the reported event, the cup was determined to be not reportable as the device is not believed to have caused or contributed to the event.The initial report was forwarded in error and should be voided.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 Description

Upon reassessment of the reported event, the cup was determined to be not reportable as the device is not believed to have caused or contributed to the event.The initial report was forwarded in error and should be voided.

• Brand Name: UNK CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15083816
• MDR Text Key: 296381085
• Report Number: 0001822565-2022-02127
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: UNK HEAD.; UNK LINER.; UNK STEM.
• Patient Outcome(s): Required Intervention