MAUDE Adverse Event Report: BIOMET ORTHOPEDICS HIP MOLD STEM W/REINF 17X165; 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.Date of birth: ¿ 1939.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 2 of 3 mdrs filed for the same patient (reference 1825034-2016-03484, 03485 & 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.

• Brand Name: HIP MOLD STEM W/REINF 17X165
• 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: 5934534
• MDR Text Key: 54138974
• Report Number: 0001825034-2016-03485
• 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
• Report Date: 08/08/2016

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: Physician
• Device Expiration Date: 05/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 431194
• Device Lot Number: 932920
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2015
• 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