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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 22.0 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 22.0 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Impaired Healing (2378); No Information (3190)
Event Date 09/02/2016
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. Concomitant medical products: item # 650-1057, 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 - 05929, 0001825034 - 2018 - 05930, 0001825034 - 2018 - 05931.
 
Event Description
It was reported that approximately 1 month post implantation, the patient was recommended for a wound revision due to unknown reasons. The patient chose to treat the wound conservatively and was given oral antibiotics. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. 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. Insufficient information.
 
Event Description
It was reported that approximately 1 month post implantation, the patient was recommended for a wound revision due to delayed wound healing and superficial infection. The patient chose to treat the wound conservatively and was given oral antibiotics. Attempts have been made and no further information has been provided.
 
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Brand NameTPRLC 133 MP TYPE1 PPS HO 22.0
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 Key7767907
MDR Text Key116594605
Report Number0001825034-2018-05927
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK110400
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2018
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
Device Catalogue Number51-107220
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 Received08/14/2018
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

Patient Treatment Data
Date Received: 08/09/2018 Patient Sequence Number: 1
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