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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK ZNN NAIL PROSTHESIS, TRAUMA

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ZIMMER BIOMET, INC. UNK ZNN NAIL PROSTHESIS, TRAUMA Back to Search Results
Catalog Number UNK ZNN NAIL
Device Problem Migration (4003)
Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Event Date 04/03/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: item# 00223200418, lot# 64588005; item# 40248403550, lot# 64342364; item# unk, lot# 2973566; item# unk, lot# 2976756. Mfr site: foreign - event occurred in (b)(6). 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. 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.
 
Event Description
It was reported patient underwent an initial procedure of right femur fixation closed reduction and internal fixation approximately one (1) year and two (2) months ago caused by a fall. Subsequently, patient was revised approximately seven (7) weeks later and the unknown znn nail was explanted due to the nail cutting out and migrating caused by poor bone quality. Patient was re-implanted approximately two (2) weeks later with a right hip femoral head prosthesis. Attempts have been made and no further information has been provided.
 
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Brand NameUNK ZNN NAIL
Type of DevicePROSTHESIS, TRAUMA
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 Key11736967
MDR Text Key248370366
Report Number0001822565-2021-01175
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK ZNN NAIL
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 Received04/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 04/28/2021 Patient Sequence Number: 1
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