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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS SO 12.0 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS SO 12.0 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Impaired Healing (2378)
Event Date 06/30/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Unique identifier (udi) #: n/a. Item # unk, head, lot # unk; item # unk, shell, lot # unk; item # unk, liner, lot # unk. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 05411; 0001825034 - 2018 - 05412; 0001825034 - 2018 - 05413.
 
Event Description
It was reported that approximately 1 month post implantation, the patient underwent an i&d due to non-healing wound. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information 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. Concomitant medical products: item # 650-1057, head, lot # unk, item # unk, shell, lot # unk, item # unk, liner, lot # unk, item # 650-1064, taper, lot # unk. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09760.
 
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Brand NameTPRLC 133 MP TYPE1 PPS SO 12.0
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7761786
MDR Text Key116391184
Report Number0001825034-2018-05410
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
PK110400
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup
Report Date 10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number51-106120
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2018
Is This a Reprocessed and Reused Single-Use Device? No

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