MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP RASP 16X117MM; INSTRUMENT, HIP

Model Number N/A

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign: canada.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that there was a chip missing out of the broach, the device had fractured.The hospital suspects it happened during reprocessing which has caused the device to be unusable.There was no patient impact or involvement.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Tprlc 133 mp rasp 16x117mm, part # 51-206160 from lot zb161002, was returned and evaluated against the complaint.The size and lot etching on the returned device was verified to match the complaint.Visual inspection found a chip in the coating between the teeth.A review of the device history records identified no deviations or anomalies during manufacturing.Reported event did not occur in the operating room or as part of a medical procedure.A definitive root cause cannot be determined.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

There is no update to the prior event description provided.

• Brand Name: TPRLC 133 MP RASP 16X117MM
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18078232
• MDR Text Key: 327489114
• Report Number: 0001825034-2023-02592
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00880304516823
• UDI-Public: (01)00880304516823(11)161104(10)ZB161002
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• 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: 51-206160
• Device Lot Number: ZB161002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1