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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. IMPACT HI-WALL LNR 28MM SIZE 4 PROSTHETIC, HIP

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ZIMMER BIOMET, INC. IMPACT HI-WALL LNR 28MM SIZE 4 PROSTHETIC, HIP Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Naturally Worn (2988)
Patient Problems Cyst(s) (1800); Pain (1994)
Event Date 08/20/2009
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: item # 163132 item name 28mm mod hd ceramic std nk lot #163132. Item # 103531 item name ti low profile screw 6. 5x20mm lot #083740. Item # 103530 item name ti low profile screw 6. 5x15mm lot #442770. The device will not be returned for analysis as product location is unknown; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04445.
 
Event Description
It was reported the patient underwent a right tha on an unknown date approximately 13 years later the patient was revised due to wear likely secondary to vertical position of the cup. The patient had a recent accident at work and went to see his physician with mild buttock and thigh pain. It was also noted the patient had an osteolytic cyst during the procedure which was removed. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameIMPACT HI-WALL LNR 28MM SIZE 4
Type of DevicePROSTHETIC, 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 Key11109259
MDR Text Key224811531
Report Number0001825034-2020-04446
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/1997
Device Model NumberN/A
Device Catalogue Number112024
Device Lot Number532880
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 Received03/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/1992
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: 01/04/2021 Patient Sequence Number: 1
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