MAUDE Adverse Event Report: BIOMET ORTHOPEDICS FRDM CNSTR HD 36MM T12/14 -6MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Information (3190)

Event Date 07/06/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.This report is number 2 of 2 mdrs filed for the same patient (reference 1825034-2016-03035 / 03036).

Event Description

During a total hip arthroplasty, the femoral head would not engage the stem, another head was tried with the same result.The surgeon removed all implants and completed the procedure with competitor product.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products - g7 acetabular cup catalog#: 110010263 lot#: 3658973, g7 acetabular liner catalog#: 010000982 lot#: 3433505, g7 screw catalog#: 010000999 lot#: 3678645 & 3727754, zimmer femoral stem catalog#: 00784301226 lot#: 62832452.Complaint sample was evaluated and the reported event was confirmed.Dimensional analysis found the device to be within specification, and dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to surgeon misuse, as the stem and head are incompatible.A previous field communication states that these components are not compatible and should not be used together.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will contribute to monitor for trends.

• Brand Name: FRDM CNSTR HD 36MM T12/14 -6MM
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5868552
• MDR Text Key: 51849084
• Report Number: 0001825034-2016-03036
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK043537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 14-107016
• Device Lot Number: 182600
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention