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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI LOW PROFILE SCREW 6.5X35MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TI LOW PROFILE SCREW 6.5X35MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994); Post Operative Wound Infection (2446)
Event Date 11/26/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event. Please also see associated report(s): 0001825034 - 2018 - 01094, 0001825034 - 2018 - 01095, 0001825034 - 2018 - 01096, 0001825034 - 2018 - 01098, 0001825034 - 2018 - 01099, 0001825034 - 2018 - 01100, 0001825034 - 2018 - 01102, 0001825034 - 2018 - 01103, 0001825034 - 2018 - 01104, 0001825034 - 2018 - 01105, 0001825034 - 2018 - 01106. Concomitant medical products: pm156856 higgins triflange 836820, 11-300918 arcos 18x190mm spl 251050, 163669 32mm mod head cocr 898680, 11-107004 r/c ii constrained 968020, 11-301310 arcos con sz a hi 650020, 103534 ti low profile screw 488910, 103534 ti low profile screw 998730 103535 ti low profile screw 998800, 103535 ti low profile screw 387710, 103533 ti low profile screw 980220, 103532 ti low profile screw 372110, 103532 ti low profile screw 364410. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported a patient underwent right hip incision and debridement 21 days post-implantation due to wound drainage and pain.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information. Reported event was confirmed by review of operative notes. The x-rays were received, but not reviewed as the complaint event is related to infection. Per the operative report, the patient was taken to surgery due to infection and pain. An incision and debridement was performed. No components were revised. There is no mention of osteomyelitis in the operative report. Dhr was reviewed and no discrepancies were found. Root cause was unable to 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 6.5X35MM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7278927
MDR Text Key100390940
Report Number0001825034-2018-01107
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
PK082446
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number103534
Device Lot Number488910
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/16/2018 Patient Sequence Number: 1
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