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

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown broach.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon attempted to use a size 11 high offset taperloc stem in the patient, and it was noted that the stem was set too proud.However, when the surgeon had initially put the broach down, it was flush.Subsequently, a smaller sized stem had to be used.No additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - stem.One tprlc 133 t1 pps ho 11x142mm item#: 51-104110, lot#: 7178477 was returned and evaluated.Upon visual inspection there was a scratch noted on the flat of the stem.There was no visible damage to the threads of the device.No further damage was found on the device.Medical records were not provided.A review of the device history records identified no deviations or anomalies during manufacturing.The investigation could not verify or identify any evidence of product contribution to the reported problem.The surgical technique states that the stem is designed to achieve a tight press-fit in the femoral canal and thus should sit flush or slightly proud relative to the broach.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.

Event Description

No further event information is available at the time of this report.

• Brand Name: TPRLC 133 T1 PPS HO 11X142MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16033091
• MDR Text Key: 307904103
• Report Number: 0001822565-2022-03421
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00880304489714
• UDI-Public: (01)00880304489714(17)320317(10)7178477
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-104110
• Device Lot Number: 7178477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• 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 Sequence Number: 1
• Patient Sex: Female