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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AVENIR CMPL HA STD NC SIZE 2 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. AVENIR CMPL HA STD NC SIZE 2 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Positioning Problem (3009)
Patient Problem Bone Fracture(s) (1870)
Event Date 02/17/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: catalog number: 574101030, lot number: 3037909, brand name: avenir cmpl ha std nc size 3 unknown broach. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00514, 0001822565-2021-00675. 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.
 
Event Description
It was reported during an initial hip arthroplasty, that the surgeon broached with a size 2 broach. However, when he implanted the size 2 stem implant, it sank further into the bone canal than the broach. The surgeon broached then with a size 3 broach to further prep the canal. The size 3 stem implant, was implanted into the bone canal and also sank further into the canal than the broach. There was no apparent bone fractures as confirmed by radiographs. The size 3 implant was removed and the surgeon continued to further broach until it was determined that a size 6 broach was the largest size the patient¿s anatomy could accommodate. Another radiograph was taken and this time there was clearly a bone fracture in the lateral femur at the level of the distal end of the broach. The surgeon applied cerclage cables and bypassed the fracture using an acros modular revision stem. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameAVENIR CMPL HA STD NC SIZE 2
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 Key11456733
MDR Text Key241746605
Report Number0001822565-2021-00513
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number574101020
Device Lot Number3032773
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 Received06/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2020
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: 03/10/2021 Patient Sequence Number: 1
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