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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARCOS CON SZ B STD 70MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ARCOS CON SZ B STD 70MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Patient Problems Failure of Implant (1924); Joint Dislocation (2374)
Event Date 06/03/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: 00631005836 ¿ liner ¿ unknown lot; 11-262661 ¿ cocr head ¿ 814600; unknown arcos stem ¿ unknown part and lot; unknown cup ¿ unknown part and lot. Report source (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for the investigation as it is unavailable by hospital policy. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that patient underwent a hip revision after an unknown amount of time post implantation to correct anteversion of the cone body of the stem. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameARCOS CON SZ B STD 70MM
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 Key11997741
MDR Text Key256165947
Report Number0001825034-2021-01775
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K090757
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number11-301333
Device Lot Number036340
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 Received10/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2017
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: 06/15/2021 Patient Sequence Number: 1
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