MAUDE Adverse Event Report: TPRLC XR FP TYPE1 PPS 7X134MM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pneumonia (2011); Thrombosis/Thrombus (4440)

Event Date 06/21/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -02575, 0001825034 -2021 -02576.

Event Description

It was reported the patient underwent initial right total hip arthroplasty.Subsequently, one week postop, the patient developed pneumonia and was hospitalized for one week.Two weeks later, the patient developed a dvt and was treated in the hospital overnight.By the one month visit, the patient reported high satisfaction with only slight pain and problems.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported the patient underwent initial right total hip arthroplasty.Subsequently, one week postop, the patient developed pneumonia and was hospitalized for one week.Two weeks later, the patient developed a dvt and was treated in the hospital overnight.By the one month visit, the patient reported high satisfaction with only slight pain and problems.At the 3 month visit, the patient reported slight pain/problems, pain 2/10, very satisfied.No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: b5, d10.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device history records were not reviewed as the root cause was unrelated to the zimmer biomet device.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Pneumonia is a well-known postoperative complication that typically requires medical intervention and possibly even hospitalization for more aggressive medical management.During the immediate postoperative period for a period of 2 hours, the protective reflexes are depressed and the patient can aspirate.Typically, the reason for postoperative pneumonia is the aspiration of subglottic secretions containing bacteria.Once the bacteria enters the respiratory tract, they can replicate if the conditions are right and advance into aspiration pneumonia.Patients that have known history of respiratory or lung diseases, such as inhaler use in this patient, are at increased risk for developing this complication.Pneumonia is a procedure-related complication resulting from intubation during the procedure.Deep vein thrombosis (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 postoperative 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 post-operative complications of dvt and pneumonia developed and medical intervention was required to treat these postoperative procedure-related complications.The root cause of the reported procedure-related event was determined to not be traced to the device.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: TPRLC XR FP TYPE1 PPS 7X134MM
• Type of Device: PROSTHESIS, HIP
• MDR Report Key: 12421314
• MDR Text Key: 269762006
• Report Number: 0001825034-2021-02577
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2021

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: 51-102070
• Device Lot Number: 6945473
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 09/07/2021; 11/02/2021
• Supplement Dates FDA Received: 09/28/2021; 11/04/2021
• 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: BIOMET BIOLOXD HEAD CAT#12-115114 LOT#2983186; BIOMET BIOLOXD HEAD CAT#12-115114 LOT#298386; BIOMET BIOLOXD HEAD CAT#12-115114 LOT#298386
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 69