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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X40MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X40MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problems Ossification (1428); Pain (1994); Scar Tissue (2060); Joint Dislocation (2374)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device will not be returned for analysis; 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 -2019 -05735, 0001825034 -2019 -05737.
 
Event Description
It was reported the patient underwent right tha. Subsequently, patient suffered a dislocation approximately 8 months later and was treated with unsuccessful closed reduction. Right revision was performed 2 days later due to the dual mobility bearing had dissociated from the biolox head. Extensive scar tissue, heterotopic ossification surrounding acetabulum component was noted. Difficulty with seating of head/liner, removed and performed additional debridement and was able to place liner and reduce hip without further issues. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameACT ARTIC E1 HIP BRG 28X40MM
Type of DevicePROSTHESIS, 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 Key9519317
MDR Text Key173163883
Report Number0001825034-2019-05736
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberEP-200146
Device Lot Number820680
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/21/2018
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 Treatment Data
Date Received: 12/26/2019 Patient Sequence Number: 1
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