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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091); Toxicity (2333)

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Date implanted - between (b)(6) 2005 to (b)(6) 2006.Date explanted - unknown.(b)(6).Pma/510(k) number.Manufacture date ¿ unknown.Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure occurred.  should additional information be received regarding the revision procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, ¿material sensitivity reactions.¿ number 8 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions." number 14 states, "intraoperative or postoperative bone fracture and/or postoperative pain." number 15 states, "elevated metal ion levels have been reported with metal on metal articulating surfaces." this information was originally reported on 1825034-2016-00223 which referenced a journal article written on a study that this patient took part in.

Event Description

Information was received based on review of a journal article titled, "adverse reaction to metal debris after recap-m2a-magnum large-diameter-head metal-on-metal total hip arthroplasty" which aimed to assess the prevalence of and risk factors for armd with the recap-m2a-magnum ldh mom tha.A patient was identified in the article that underwent total hip arthroplasty between (b)(6) 2005 to (b)(6) 2006.Subsequently, patient was revised on an unknown date due to moderate pain, sensation of subluxation, swelling, and elevated metal ions.No further information has been provided.During the revision procedure, it was noted that the femoral head was cold-welded to the adapter and trunnion.An extended trochanter osteotomy was performed to revise the stem.Additionally, a mri scan revealed a pseudotumor.No further information has been provided.

• 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: 5377737
• MDR Text Key: 36323050
• Report Number: 0001825034-2016-00226
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PUNKNOWN
• 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: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• 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
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR