MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 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

A journal article was retrieved from journal of orthopaedics and traumatology (2021) that reported a retrospective study from italy.The purpose of the study was to evaluate the long-term survival and clinical and radiological results of conus uncemented stems, implanted in patients affected by hip osteoarthritis with crowe not-type iv secondary to developmental hip dysplasia.The study reviewed 100 total hips / 87 patients.The majority of the patients were female, that is, 63 women and 24 men with a mean age of 53 years (range 27¿88 years); all of them were identified as white/caucasian.Thirteen patients underwent bilateral tha consecutively, not simultaneously.The right hip was operated in 64 cases, the left in 36.The patients¿ mean body mass index (bmi) was 29.8 (range 27.1¿35.6).All were performed using a direct lateral approach without cement.The zimmer-biomet continuum shell was used 27 in cases, a zimmer-biomet trilogy shell was used in 22 cases, and a zimmer-biomet tmt modular shell was used in 18 cases.Other acetabular components used included protek allocor in 13 cases, protek fitek in 10, sulzer fitmore in 4, link top in 3, aesculap plasmacup in 2, and centrepulse allofit in 1.Two or more additional acetabular screws were used in 71 cases to implement fixation based on the bone quality of the patient and the preference of the surgeon.In all cases, a wagner femoral cone prosthesis was implanted into the femur.The mean follow-up of the study was 11.7 years (range 2.2¿21.8 years) with a minimum follow up of 2 years.The study reported one patient experienced a deep venous thrombosis on the fifth postoperative day that resolved without sequelae with medical therapy.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Report source: journal article: solarino et al.J orthop traumatol (2021) 22:16 https://doi.Org/10.1186/s10195-021-00578-8.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Report source: journal article: solarino et al.J orthop traumatol (2021) 22:16 https://doi.Org/10.1186/s10195-021-00578-8.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

A journal article was retrieved from journal of orthopaedics and traumatology (2021) that reported a retrospective study from italy.The purpose of the study was to evaluate the long-term survival and clinical and radiological results of conus uncemented stems, implanted in patients affected by hip osteoarthritis with crowe not-type iv secondary to developmental hip dysplasia.The study reviewed 100 total hips / 87 patients.The majority of the patients were female, that is, 63 women and 24 men with a mean age of 53 years (range 27¿88 years); all of them were identified as white/caucasian.Thirteen patients underwent bilateral tha consecutively, not simultaneously.The right hip was operated in 64 cases, the left in 36.The patients¿ mean body mass index (bmi) was 29.8 (range 27.1¿35.6).All were performed using a direct lateral approach without cement.The zimmer-biomet continuum shell was used 27 in cases, a zimmer-biomet trilogy shell was used in 22 cases, and a zimmer-biomet tmt modular shell was used in 18 cases.Other acetabular components used included protek allocor in 13 cases, protek fitek in 10, sulzer fitmore in 4, link top in 3, aesculap plasmacup in 2, and centrepulse allofit in 1.Two or more additional acetabular screws were used in 71 cases to implement fixation based on the bone quality of the patient and the preference of the surgeon.In all cases, a wagner femoral cone prosthesis was implanted into the femur.The mean follow-up of the study was 11.7 years (range 2.2¿21.8 years) with a minimum follow up of 2 years.The study reported one patient experienced a deep venous thrombosis on the fifth postoperative day that resolved without sequelae with medical therapy.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The study reported one patient experienced a deep venous thrombosis on the fifth postoperative day that resolved without sequelae with medical therapy.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.The complaint indicated a post-operative complication developed and medical intervention was required to treat the complication.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 event information available at the time of this report.

• Brand Name: UNKNOWN CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13601080
• MDR Text Key: 286164011
• Report Number: 0001822565-2022-00608
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 02/25/2022
• Supplement Dates Manufacturer Received: 03/04/2022
• Supplement Dates FDA Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNKNOWN WAGNER STEM
• Patient Outcome(s): Other; Required Intervention