MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN HIP; HIP PROSTHESIS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patient mentioned in the journal article.The article was written by olof sköldenberg, anna ekman, mats salemyr and henrik bodén.

Event Description

Information was received based on review of a journal article titled, ¿reduced dislocation rate after hip arthroplasty for femoral neck fractures when changing from posterolateral to anterolateral approach¿ which aimed to perform a retrospective analysis on 372 patients after hip arthroplasty with femoral neck fractures using the bi-metric femoral stems manufactured by biomet; and to evaluate the dislocation rate between use of the posterlateral approach and the anterolateral approach.One patient was identified in the article that underwent hip arthroplasty on an unknown date using the posterolateral approach.Patient follow-up results provided indicate that the patient underwent a closed reduction due to dislocation that occured thirty-eight days post-operatively.There has been no further information provided and the patient outcome is unknown.

Manufacturer Narrative

This follow-up report is being filed to correct information.

• Brand Name: UNKNOWN HIP
• Type of Device: HIP PROSTHESIS
• 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: 6114386
• MDR Text Key: 60418268
• Report Number: 0001825034-2016-04753
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PN/A
• 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: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 82 YR