MAUDE Adverse Event Report: BIOMET ORTHOPEDICS HIP NECK LENGTH ADAPTER +6 MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 08/09/2016

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 the lot released with no recorded anomaly or deviation.(b)(6).There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 5 states, "dislocation has been reported with two-stage revisions." this report is number 1 of 3 mdrs filed for the same patient (reference 1825034-2016-03484, 03485 and 03490).Remains implanted.

Event Description

Patient underwent an open reduction procedure four days post-implantation due to disassociation of the neck length adapter from the cement stem spacer mold.The components were reassembled.

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).

• Brand Name: HIP NECK LENGTH ADAPTER +6 MM
• 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: 5934533
• MDR Text Key: 54138536
• Report Number: 0001825034-2016-03484
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK080979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• 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: 431187
• Device Lot Number: 787010
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR