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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI LOW PROFILE SCREW PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TI LOW PROFILE SCREW PROSTHESIS, HIP Back to Search Results
Catalog Number 103531
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Swelling (2091); Impaired Healing (2378)
Event Date 10/31/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: ti low profile screw cat#103531 lot#547720. Shell with cluster holes cat#00875305001 lot#63861501. Report source: (b)(6). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05411.
 
Event Description
It was reported that the patient underwent a full artificial joint replacement and the wound showed repeated symptoms of redness, swelling, rupture and exudation after the operation. Approximately one week later, the patient underwent a dilated and invasive catheter drainage, and the wound healed upon discharge. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Udi# (b)(4). Reported event was confirmed with medical records provided. Review of the available records identified the following: patient was diagnosed with anemia and swelling post op. Infection developed shortly after implant procedure. Wound drainage, drainage tube was placed, and treated with antibiotics. Wound healed and patient discharged. Review of the device history records identified no deviations or anomalies during manufacturing. A definitive root cause cannot be determined. 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 NameTI LOW PROFILE SCREW
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9424210
MDR Text Key169511641
Report Number0001825034-2019-05410
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K082446
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number103531
Device Lot Number547580
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/06/2019 Patient Sequence Number: 1
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