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

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Infarction, Cerebral (1771); Death (1802); Suffocation (2088); Toxicity (2333); Joint Dislocation (2374); Cancer (3262)

Event Type  Death  

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.The article was written by wataru ando, kengo yamamoto, takashi atsumi, satoshi tamaoki, kazuhiro oinuma, hideaki shiratsuchi, hirohiko tokunaga, yutaka inaba, naomi kobayashi, masaharu aihara and kenji ohzono.

Event Description

Information was received based on review of a journal article titled, "comparison between component designs with different femoral head size in metal-on-metal total hip arthroplasty; multicenter randomized prospective study" which aimed to investigate potential advantages of magnum group compared to conventional group in terms of range of motion, dislocation while maintaining the same function improvement and pain reduction; and to investigate metal ion release in asian population.The study consisted of one hundred eighty-five (185) patients that required total hip arthroplasty.During the study, three (3) patient deaths occurred due to gall bladder cancer, cerebral infarction, and suffocation before two year follow up with components in situ.The cobalt ion levels of five (5) patients increased higher than 7 mg/l.One of the patients experiencing elevated metal ion levels also experienced dislocation.In conclusion, large head mom tha showed good clinical results with no dislocation case reported and showed significantly lower metal ion release than conventional mom group if the implants were positioned in appropriate alignment at two years postoperatively.

• 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: 5323760
• MDR Text Key: 34260304
• Report Number: 0001825034-2015-05110
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/15/2015

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
• Device Catalogue Number: UNKOWN HIP
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 12/23/2015
• 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): Death; Hospitalization; Required Intervention