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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BIOMET INTERGRAL 180, PRIMARY STEM 14*180 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN BIOMET INTERGRAL 180, PRIMARY STEM 14*180 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem No Apparent Adverse Event (3189)
Patient Problem Blood Loss (2597)
Event Date 04/19/2012
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 163663 28mm dia cocr mod hd +3mm nk 145750,, unknown stryker trident acetabular component size 62 mm unknown, unknown screws 24, 26, 35 and 40 unknown, unknown standard mdm metal liner 48 id unknown, unknown stryker 48mmx3 adm femoral head poly (48 od, 28id) unknown. Customer has indicated that product will not be returned for evaluation. A follow up mdr will be submitted once the investigation is completed.
 
Event Description
It was reported that during a left hip revision arthroplasty the patient experienced 2600 ml blood loss. No additional patient consequences were reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of the provided op notes which confirmed the patient's blood loss. Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. Non- zimmer biomet shell and liner are used with zimmer head and stem. Zimmer-biomet has not assessed or confirmed the compatibility of this combination of devices, and this would be considered an off-label use of these devices. However it is unknown if this combination of devices has any effect to the reported issue 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.
 
Manufacturer Narrative
The follow up report is been submitted to relay additional information received. The additional information received does not have any change in investigation results reported previously. 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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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 Key7500874
MDR Text Key107821427
Report Number0001825034-2018-03258
Device Sequence Number1
Product Code KWY
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 health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Other Device ID 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 Received07/24/2018
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: 05/09/2018 Patient Sequence Number: 1
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