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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X54MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ACT ARTIC E1 HIP BRG 28X54MM 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 Adhesion(s) (1695); Scar Tissue (2060); Joint Dislocation (2374); Patient Problem/Medical Problem (2688)
Event Date 04/17/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: biomet biolox head cat#12-115109 lot#2886313, biomet g7 cup cat#110010271 lot#3983154, biomet liner cat#110024467 lot#058910, biomet stem cat#11-301300 lot#946930, biomet taper cat#11-300920 lot#013480. Product has been received by zimmer biomet and 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 - 2019 - 02363, 0001825034 - 2019 - 02364.
 
Event Description
It was reported patient underwent right hip revision approximately 1 year post tha. It was reported during an office visit approximately 1 year later, that the patient sustained multiple dislocations and was recently reduced in the emergency department. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Operative notes were provided. Review of the notes demonstrated subfascial adhesions due to previous incisions, reddish synovial fluid noted (unremarkable), adductor tenotomy performed due to limited range of motion per patient anatomy, no intraop complications noted. Additional information does not change the previous summary. 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
It was reported patient underwent an initial right total hip arthroplasty on an unknown date with unknown product. The patient was revised to an arcos revision system approximately 1 year later. Subsequently, it was noted during an office visit approximately 1 year later, the patient sustained multiple dislocations and was reduced in the emergency department. It was further reported that during the reduction, the g7 bearing disassociated from the biolox head. This led to a second revision of the right hip. Patient instructed to continue physical therapy but avoid the motions that cause dislocation. No further event information available at the time of this report.
 
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Brand NameACT ARTIC E1 HIP BRG 28X54MM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8653517
MDR Text Key146476760
Report Number0001825034-2019-02362
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
K101336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberEP-200160
Device Lot Number211710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2019
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/30/2019 Patient Sequence Number: 1
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