MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X25 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Pulmonary Embolism (1498)

Event Date 04/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: cat# 650-1057 lot# 2857354 cer bioloxd option hd 36mm cat# 650-1064 lot# 2887392 cer option type 1 tpr sleve -6 cat# 110017102 lot# 3805701 g7 finned 3 hole shell 50d cat# 010000856 lot# 3964987 g7 neutral e1 liner 36mm d cat# 51-100090 lot# 3943768 tprlc 133 fp type1 pps so 9.0.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial left total hip arthroplasty.Subsequently, the patient developed an acute pulmonary embolism 4 days later.The patient was admitted to the hospital and treated with medication.Patient was sent home in stable condition with home health care and is instructed to stay on medication for 3 months.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}: updated: d4; g3; h2; h3; h4; h6.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Deep vein thrombosis (blood clot), 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-operatively to prevent dvt formation.Despite prophylaxis, dvts can still develop which can then break free within the vessel and occlude or block the blood flow in the lungs, known as a pulmonary embolism (pe).As the complaint indicated, a post-operative complication occurred, and medical intervention was required for treatment.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

No further information at the time of this report.

• Brand Name: BONE SCR 6.5X25 SELF-TAP
• 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: 18485243
• MDR Text Key: 332565373
• Report Number: 0001822565-2024-00124
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119819
• UDI-Public: (01)00889024119819(17)270131(10)63585018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625006525
• Device Lot Number: 63585018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2017
• 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: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White