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

Model Number N/A

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Seizures (2063); Synovitis (2094); Vertigo (2134); Visual Disturbances (2140); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Product identification was not provided for the patients mentioned in the journal article.Initial reporter - the article was written by p.Burton, et al in reconstructive review vol 5, no 2 (2015).(b)(4).

Event Description

Information was received based on review of a journal article titled, "biomechanical alignment of main wear-pattern on mom total hip replacement" which aimed to investigate 1) size, shape and location of the mwz areas on the femoral head and cup, 2) damage from cup-to-stem impingement, and 3) stripe damage.A primary mom total hip was performed in (b)(6) 2008 on a (b)(6) female patient for avascular necrosis.Medical history included a single seizure associated with a febrile illness seven years prior to hip replacement surgery.Eight months postoperatively, the patient developed headaches, memory loss, vertigo, and aura-like symptoms which progressed to seizures.At twelve months postop, the patient presented with progressive hip pain and sounds of popping, gross creaking, and crepitus sensations with motion.Revision surgery was performed at 32 months postop in (b)(6) 2010.At surgery, upon entering the hip capsule, a dark, serous fluid was observed along with synovitis.The implants were well-fixed.Several attempts were made to remove the femoral head in order to retain the well-fixed stem.However, the head appeared fused to the trunnion and a femoral osteotomy was performed to remove the stem.Following revision, the patient's mental status normalized and headaches and seizures stopped.The patient has had some persistent hip pain since the revision surgery, possible related to her lumbar spine disease.In conclusion, this mom retrieval with a fused head provided confirmation of the manner in which we use wear patterns on heads and cups to deduce implant orientation in vivo.Wear patterns on femoral heads provide a good indication of habitual wear in vivo while cup wear patterns provide insight as to whether the wear was contained centrally in the cup or in fact demonstrated adverse edge wear.

• Brand Name: UNKNOWN HIP
• 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: 5064151
• MDR Text Key: 25264259
• Report Number: 0001825034-2015-03885
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN HIP
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2015
• 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: 35 YR