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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 11X142MM 2MM T1 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 11X142MM 2MM T1 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Burning Sensation (2146); Numbness (2415); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant products: catalog#: 103534 ti low profile screw 6. 5x35mm ia6. 5x35mm lot#: 624060. Catalog#: 13-104156 m/h 3hole rlc shl nrs 56mm/l24 lot#: 215780. Catalog#: 103532 bm acet lp dome scw ti s/tap d ia6. 5x25mm lot#: 120880. Catalog#: 135300 acetabular apex plug lot#: 033870. Catalog#: 11-363662 36mm cocr mod hd std lot#: 351930. Catalog#: 105994 rnglc lnr 26mm hwall 24 lot#: 464560. The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01594, 0001825034-2021-01600, 0001825034-2021-01601, 0001825034-2021-01602, 0001825034-2021-01603, 0001825034-2021-01605.
 
Event Description
It was reported the patient is experiencing a feeling like fire is running down the leg and hip, numbness, pain, feels like a tennis ball is in the butt cheek, the patient cannot ride in a vehicle for long periods, and the patient has difficulty lifting his leg approximately 4 years and 9 months post implantation. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameTPRLC 133 T1 PPS HO 11X142MM 2MM T1
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 Key11884023
MDR Text Key252610809
Report Number0001825034-2021-01608
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number51-104110
Device Lot Number3727019
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2016
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: 05/26/2021 Patient Sequence Number: 1
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