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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E-POLY 40MM +3 HIWALL LNR SZ24; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. E-POLY 40MM +3 HIWALL LNR SZ24; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Device Dislodged or Dislocated (2923); Migration (4003)
Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Joint Dislocation (2374); Reaction (2414); Limited Mobility Of The Implanted Joint (2671)
Event Date 01/16/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4).51-106150, tprlc 133 microplasty type1 pps so 15.0, 2911786; 13-104156, m/h 3hole ringloc shell nrs 56mm/l24, 578430; s001140, selex/magnum mod hd 40mm std, 670290.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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 - 2018 - 02535, 0001825034 - 2018 - 02534, 0001825034 - 2018 - 02537.
 
Event Description
It was reported that the patient's right hip was revised 0.5 years post implantation due to chronic infection, severe pain, dislocation, metallosis, component loosening, and lack of mobility.All of the components were revised and antibiotic spacers were placed.Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.
 
Event Description
It was reported that the patient's right hip was revised 0.5 years post implantation due to chronic infection, severe pain, swelling, inflammation, damage to surrounding bone and tissue,dislocation, metallosis, component loosening, and lack of mobility.Pseudocapsule dissected with purulent drainage were noted.All of the components were revised and antibiotic spacers were placed.Attempts have been made and additional information on the reported event is unavailable.
 
Event Description
It was reported that the patient's right hip was revised 0.5 years post implantation due to chronic infection, severe pain, swelling, inflammation, damage to surrounding bone and tissue,dislocation, metallosis, component loosening, and lack of mobility.Pseudocapsule dissected with purulent drainage were noted.All of the components were revised and antibiotic spacers were placed.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.Reported event was confirmed by review of operative notes.Revision op notes dated 16 jan 2014 was reviewed and it was identified the patient was revised due to stage one chronic hip infection.Revision op notes dated 28 aug 2014 were reviewed and it was identified the patient was revised due to stage two chronic hip infection.Record (dhr) was reviewed and no discrepancies were found.A definitive root cause could not be determined.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.
 
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Brand Name
E-POLY 40MM +3 HIWALL LNR SZ24
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7467731
MDR Text Key106700697
Report Number0001825034-2018-02536
Device Sequence Number1
Product Code MAY
Combination Product (y/n)N
PMA/PMN Number
PK090103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup,Followup
Report Date 01/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date03/31/2018
Device Model NumberN/A
Device Catalogue NumberEP-108524
Device Lot Number927600
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age52 YR
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