MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X30 SELF-TAP; PROSTHETIC, HIP

Model Number N/A

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

Patient Problems Pain (1994); Rash (2033); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 03/26/2023

Event Type  Injury  

Event Description

It was reported that 11 days post implantation the patient developed an ipsilateral rash, pain and swelling to the calf that was diagnosed as a dvt.The patient was placed on a medication and the dvt was considered resolved 4 months later.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).D10: (b)(6), item name: femoral stem cementless collared standard offset, 12/14 taper size 5 lot # 3129306.(b)(6), item name: 36mm i.D.Size e neutral liner, lot # 65574750.(b)(6), item name: bone scr 6.5x20 self tap, lot # j7373545.(b)(6), item name: biolox⮠delta, ceramic femoral head, l, 㸠36/+3.5, taper 12/14, lot # 3137141.(b)(6), item name: g7 pps ltd acet shell 52e, lot # 7384978.Multiple mdr reports were filed for this event, please see associated reports 0001822565 - 2023 - 03447.0001822565 - 2023 - 03448.0001822565 - 2023 - 03450.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.Even with the administration of preventive medication, dvts can still develop.As the complaint indicated, a post-operative complication occurred, and medical intervention was required for treatment.H3 other text : device remains implanted.

• Brand Name: BONE SCR 6.5X30 SELF-TAP
• Type of Device: PROSTHETIC, 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: 18276275
• MDR Text Key: 329850334
• Report Number: 0001822565-2023-03449
• Device Sequence Number: 1
• Product Code: LPH
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• 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: 00625006530
• Device Lot Number: J7423214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• 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): Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 61 KG