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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ARCOS MODULAR REVISION STEM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN ARCOS MODULAR REVISION STEM PROSTHESIS, HIP Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Granuloma (1876); Impaired Healing (2378)
Event Date 05/14/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: g7 pps ltd acet shell, catalog # 010000661, lot # 3024724; g7 neutral e1 liner, catalog # 010000847, lot # 3117789; unknown arcos modular revision cone proximal body, catalog # unknown, lot # unknown; unknown biolox delta option head, catalog # unknown, lot # unknown; unknown biolox delta option taper adapter, catalog # unknown, lot # unknown. Our investigation is ongoing. A follow-up/final report will be submitted when additional information becomes available. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-07995; 0001825034-2018-07998; 0001825034-2018-08010; 0001825034-2018-08039; 0001825034-2018-08038. Remains implanted.
 
Event Description
It was reported a patient presented with wound drainage from a pin-hole ulceration. The patient was treated with antibiotics and local wound treatment. The wound continued to drain and the patient underwent an irrigation and debridement with excision of granuloma.
 
Manufacturer Narrative
(b)(4). The follow-up report is being submitted to relay additional information. Reported event was considered confirmed by review of surgical notes. No product was returned; visual and dimensional evaluations could not be performed. Dhr review was unable to be performed as the lot number of the device involved in the event is unknown. Review of operative notes confirm that the patient underwent irrigation and debridement of left hip wound. A definitive root cause cannot be determined with the information provided. 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 NameUNKNOWN ARCOS MODULAR REVISION STEM
Type of DevicePROSTHESIS, 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 Key7771839
MDR Text Key116714735
Report Number0001825034-2018-08008
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK090757
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2018
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 NumberN/A

Patient Treatment Data
Date Received: 08/10/2018 Patient Sequence Number: 1
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