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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN TAPERLOC STEM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN TAPERLOC STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Impaired Healing (2378)
Event Date 12/29/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant devices ¿ unknown head catalog #: ni lot #: ni, unknown shell, catalog #: ni, lot #: ni, unknown liner ,catalog #: ni, lot #: ni. It is indicated by the complainant that the devices will not be returned to zimmer biomet for investigation, as the devices remain implanted. The complaint sample was not evaluated, but the reported event was confirmed through review of medical records. A device history record review was unable to be performed as the lot number of the device involved in the event is unknown. Review of operative notes confirms that the patient underwent local superficial wound debridement and closure. Indication was large nonhealing central necrotic area, which appears to be skin and fat necrosis. It did not appear to be infected. The wound was debrided and irrigated with no additional findings noted. The complaint documents stated results of cbc, esr, and crp levels were within normal limits when the patient returned a few days post-debridement. A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08052; 0001825034-2018-08053; 0001825034-2018-08054. Device remains implanted.
 
Event Description
It was reported that the patient underwent superficial wound debridement and closure to treat non-healing in the central necrotic area less than two (2) months following hip arthroplasty. No additional patient consequences were reported.
 
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Brand NameUNKNOWN TAPERLOC 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 Key7772304
MDR Text Key116735882
Report Number0001825034-2018-08051
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/10/2018
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
Device Model NumberN/A
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 Received07/12/2018
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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