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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIPLOOP INLINE; FASTNER, FIXATION
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ZIMMER BIOMET, INC. ZIPLOOP INLINE; FASTNER, FIXATION Back to Search Results
Catalog Number 110017463
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Pain (1994); Loss of Range of Motion (2032)
Event Date 09/02/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4).Foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.
 
Event Description
It was reported a patient had an initial right acl repair.Subsequently, the patient developed a hematoma causing increased pain and restriction of mobility.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h10.It is not unexpected for a patient to develop pain, swelling, or decreased range of motion after surgery.Additionally the hematoma resolved without intervention; therefore, this complaint will be routed to not a complaint.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.
 
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Brand Name
ZIPLOOP INLINE
Type of Device
FASTNER, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10162977
MDR Text Key196213510
Report Number0001825034-2020-02399
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number110017463
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ZIPLOOP BUTTON 10MM CAT: 110010873 LOT: UNK
Patient Outcome(s) Other;
Patient Age26 YR
Patient Weight69
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