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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN LINER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)
Event Date 03/12/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4). Reported event was confirmed by review of operative notes. Concomitant medical products: unknown taperloc stem, catalog#: unk, lot#: unk; unknown head, catalog#: unk, lot#: unk; unknown cup, catalog#: unk, lot#:unk. Device history record (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 due to wound dehiscence distally and drainage. Upon entry, subcutaneous hematoma identified and evacuated. All nonviable appearing tissue debridement. Debridement did not extend into the fascia. Wound closed without further complication. Information included in the per form reported that intraoperative cultures were positive for gram positive cocci, staphylococcus, coagulase negative. This cannot be confirmed, however, as medical records or lab results that include this diagnosis were not provided. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-07681, 0001825034-2018-07696, 0001825034-2018-07728.
 
Event Description
It was reported that a patient initially underwent a total left hip arthroplasty. Patient presented 11 days post op with wound dehiscence distally and drainage. The patient underwent irrigation and debridement of the left hip due to non healing surgical wound. No additional information is available.
 
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Brand NameUNKNOWN LINER
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 Key7767979
MDR Text Key116595961
Report Number0001825034-2018-07737
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 08/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
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: 08/09/2018 Patient Sequence Number: 1
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