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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. E1 RINGLOC BIPOLAR 28X46MM; PROSTHESIS, HIP Back to Search Results
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.
 
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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 Key13953237
MDR Text Key288275771
Report Number0001825034-2022-00766
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K051569
Number of Events Reported1
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 NumberN/A
Device Catalogue Number110010465
Device Lot NumberN/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 Received03/30/2022
Supplement Dates Manufacturer Received04/07/2022
05/09/2022
Supplement Dates FDA Received05/04/2022
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 NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age72 YR
Patient SexFemale
Patient Weight60 KG
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