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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT PROSTHESIS HIP

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ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT PROSTHESIS HIP Back to Search Results
Catalog Number 00771100610
Device Problems Corroded (1131); Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Event Date 07/13/2020
Event Type  Injury  
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. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item #: 00620205222, shell, lot #: 61280318. Item #: 00630505036, liner, lot #: 61245220. Item #: 00801803602, head, lot #: 61288475. Item #: 00625006525, bone screw, lot #: 61246396. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 -00774.
 
Event Description
It was reported that patient underwent right hip revision surgery 10 years post implantation due to pain, pseudotumor and elevated metal ion. During the revision, significant corrosion was observed between the head and neck junction with resultant damage to the surrounding adductors. The head and liner were replaced without complication. Attempts have been made and no additional information is available at this time.
 
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Brand NameFEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT
Type of DevicePROSTHESIS HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key11772994
MDR Text Key250684841
Report Number0001822565-2021-01227
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Catalogue Number00771100610
Device Lot Number61158129
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 Received07/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2009
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: 05/04/2021 Patient Sequence Number: 1
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