MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BI-METRIC X-SERIES HIP SYSTEM STANDARD FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported bi-metric stem is missing parts.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Upon reassessment, it was identified that no adverse event was reported and the issue has not been previously reported to have caused a serious injury.The previously submitted report should be voided.

• Brand Name: BI-METRIC X-SERIES HIP SYSTEM STANDARD FEMORAL STEM
• 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: 6648279
• MDR Text Key: 77842605
• Report Number: 0001825034-2017-04104
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PK030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: X21-180310
• Device Lot Number: 801680
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/16/2017
• Supplement Dates Manufacturer Received: 03/14/2018
• Supplement Dates FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1