MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 RINGLOC BIPOLAR 28X46MM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Pulmonary Embolism (1498)

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).Takuya nakamura, toru yamakawa , junji hori , hisataka goto , akihiko nakagawa , tetsuro takatsu , naoki osamura , atsushi saito , keisuke hagio and kanto mouri.(2021) conjoined tendon preserving posterior approach in hemiarthroplasty for femoral neck fractures: a prospective multicenter clinical study of 322 patients.Journal of orthopaedic surgery.29 (3) 1-8.Https://doi.Org/10.1177/23094990211063963.Concomitant products: unknown ringloc bipolar cup; unknown taperloc stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00765.The device will not be returned for analysis, due to location of device is unknown; 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

It was reported in a journal article that 1 patient experienced posteroperative pulmonary embolism in an unknown time frame postoperatively.The patient was noted to have recovered but treatment and intervention details were not provided.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.D10: catalog number: 6501159 lot: unknown brand: biolox head.Catalog number: 51100080 lot: unknown brand: taperloc stem.Catalog number: 110010465 lot: unknown brand: e1 ringloc bipolar cup.

Event Description

It was reported in a journal article that the patient developed low cardiac output and oxygen levels.The patient was subsequently diagnosed with a pulmonary embolism which was noted to be resolved approximately 18 days later.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h1, h2, h3, h6, h10 procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.If a dvt/ blood clot breaks free, it may travel through the bloodstream and block blood flow to the lungs.This complication is called a pulmonary embolism.Total joint patients are typically placed on medication post-operative for a period of time to help prevent the development of dvt/blood clot formation that can lead to an pe.As the complaint indicated the patient developed a post-operative complication, it can be implied medical intervention was completed to treat the pe.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet 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: E1 RINGLOC BIPOLAR 28X46MM
• 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: 13953237
• MDR Text Key: 288275771
• Report Number: 0001825034-2022-00766
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051569
• 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,Followup
• Report Date: 05/20/2022

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
• Device Catalogue Number: 110010465
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 04/07/2022; 05/09/2022
• Supplement Dates FDA Received: 05/04/2022; 05/20/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 60 KG