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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ A STD 50MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ARCOS CON SZ A STD 50MM PROSTHESIS, HIP Back to Search Results
Catalog Number 11-301300
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Malunion of Bone (4529)
Event Date 08/05/2021
Event Type  Injury  
Event Description
It was reported a patient underwent hip revision surgery approximately 2. 5 years post implantation due to infection, periprosthetic fracture, malunion and loosening. No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown. Medical records/radiographs were provided and reviewed by a health care professional. A review of the available records identified findings of the reported issues mmi: impressions: moderate-sized periprosthetic zone of lucency in the right femoral component located at the trochanteric and subtrochanteric region suggests loosening and/or infection. Device history record (dhr) was reviewed and no discrepancies were found. Root cause was unable to 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. Concomitant medical products: catalog#: 11-300812 arcos 12x150mm spl tpr dist lot#: 303240. (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02539.
 
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Brand NameARCOS CON SZ A STD 50MM
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 Key13178780
MDR Text Key283403309
Report Number0001825034-2022-00017
Device Sequence Number1
Product Code MAY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K090757
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation
Type of Report Initial
Report Date 01/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number11-301300
Device Lot Number981060
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/06/2022 Patient Sequence Number: 1
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