MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN MALLORY-HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Osteolysis (2377)

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 patients mentioned in the journal article.Initial reporter - the article was written takashi murayama, md; hideo ohnishi, md, phd; satoshi okabe, md; hiroshi tsurukami, md, phd; toshiharu mori, md, phd; nariaki nakura, md; soshi uchida, md, phd; akinori sakai, md, phd; toshitaka nakamura, md, phd.

Event Description

Information was received based on review of a journal article titled, " 15-year comparison of cementless total hip arthroplasty with anatomical or high cup placement for crowe i to iii hip dysplasia," which aimed to compare 15 years of clinical and radiological outcomes for cementless tha for crowe i to iii developmental dysplasia of the hip with anatomical cup placement with bulk bone grafting and with high hip center placement without bulk bone grafting in 68 hips.Two patients were identified in the article that underwent total hip arthroplasty on an unknown date with the high placement technique who experienced acetabular cup osteolysis.There has been no further information provided and the patient outcomes are unknown.

• Brand Name: UNKNOWN MALLORY-HEAD
• 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: 6088766
• MDR Text Key: 59456461
• Report Number: 0001825034-2016-04554
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2016

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?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/09/2016
• 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): Other