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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 Insufficient Information (3190)
Patient Problems Hematoma (1884); Impaired Healing (2378)
Event Date 08/19/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Reported event was confirmed due to medical record review received from the customer. Device history record (dhr) review was unable to be performed as the 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. 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. Not returned to manufacturer.
 
Event Description
It was reported patient underwent total hip arthroplasty on (b)(6) 2016. One day left total hip arthroplasty, the patient underwent an incision and drainage of the left hematoma and closure of wound due to left hip hematoma and nonhealing wound. No further information available.
 
Manufacturer Narrative
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 TAPERLOC STEM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7796734
MDR Text Key117573581
Report Number0001825034-2018-08287
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup
Report Date 09/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/20/2018 Patient Sequence Number: 1
Treatment
UNK PART/LOT, LINER, HEAD, CUP; UNK PART/LOT, LINER, HEAD, CUP
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