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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZB 12/14 COCR FRDM 36MM X +6; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. ZB 12/14 COCR FRDM 36MM X +6; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Hematoma (1884); Loss of Range of Motion (2032); Scar Tissue (2060); Joint Dislocation (2374); Muscle/Tendon Damage (4532)
Event Date 10/28/2021
Event Type  Injury  
Event Description
It was reported the patient underwent initial left hip hemiarthroplasty.The patient was converted to a total hip arthroplasty approximately 3 years later.The patient underwent head and liner exchange approximately 6 months later to recurrent dislocations.The patient was revised again approximately 3 weeks later due to recurrent dislocations and psoas tendon rupture.The head and liner were exchanged without complication.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4).Concomitant products: ref 110010245 lot 64866560 shell; ref 00-7850-013-00 lot 63992895 femoral stem.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 03250.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 1822565.
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 1822565.
 
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Brand Name
ZB 12/14 COCR FRDM 36MM X +6
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 Key12909578
MDR Text Key281526912
Report Number0001825034-2021-03251
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183457
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number802403605
Device Lot Number3018288R01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/25/2022
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
Treatment
SEE H10 NARRATIVE
Patient Outcome(s) Required Intervention; Hospitalization;
Patient SexMale
Patient Weight97 KG
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