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

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.

• Brand Name: TPRLC 133 T1 PPS HO 11X142MM 2MM T1
• Type of Device: PROSTHESIS, 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 Key: 11884023
• MDR Text Key: 252610809
• Report Number: 0001825034-2021-01608
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• 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 Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 51-104110
• Device Lot Number: 3727019
• 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 Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 05/26/2021 Patient Sequence Number: 1