MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TPRLC 133 FP TYPE1 PPS HO 20.0; PROSTHESIS, HIP

Model Number N/A

Device Problems Use of Device Problem (1670); Component or Accessory Incompatibility (2897); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hip Fracture (2349)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is still in process.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported during an initial total hip replacement the surgeon unknowingly handed the surgeon a standard profile stem implant and it fractured at the distal end of the stem.There was a 30 min delay.No revision procedure has been reported to date.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: unknown reduced profile taperloc broach, part# unk, lot# unk.Reported event was confirmed by review of x-rays provided.The x-ray provided verified the event of preprosthetic fracture at the distal end of the femur.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.It was reported reduced profile taperloc complete rasp was used with standard profile stem.This is a incorrect rasp to stem relationship.Investigation results concluded that the reported event was due to an incorrect rasp handed to the surgeon during the procedure.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.

• Brand Name: TPRLC 133 FP TYPE1 PPS HO 20.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6594906
• MDR Text Key: 76078312
• Report Number: 0001825034-2017-03416
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 51-101200
• Device Lot Number: 3185998
• Other Device ID Number: (01) 00880304499171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2017
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2013
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 109