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

Device Problem Insufficient Information (3190)

Patient Problem Ossification (1428)

Event Date 07/04/2013

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.Initial reporter ¿ the article was written by weird p.Zijlstra, hugo c.Van der veen, inge van den akker-scheek, mark j.M.Zee, sjoerd k.Bulstra and jos j.A.M.Van raay involving the netherlands hospitals medical centre leeuwarden, martini hospital and university medical centre groningen.

Event Description

Information was received based on review of a journal article titled, ¿acetabular bone density and metal ions after metal-on-metal versus metal-on-polyethylene total hip arthroplasty; short-term results¿ which aimed to examine the clinical results following total hip arthroplasty in a study of 70 patients that may have experienced a decrease in acetabular bone density due to the use of metal on metal and metal-on-polyethylene implants using the m²a-magnum, advantage and mallory-head acetabular components and arcom polyethylene liners manufactured by biomet; and to investigate the comparison between the use of metal-on-metal implants and metal-on-polyethylene implants.Two patients were identified in the article that underwent hip arthroplasties on unknown dates.Patient follow-up results provided indicate that the patient experienced grade 2 periarticular ossification using metal-on-metal implantation.There has been no further information provided and the patient outcome is unknown.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Medical products - unknown femoral head, unknown mallory head stem, unknown m2a magnum cup, all catalog#'s: ni all lot's#: ni.Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined, as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will contribute to monitor for trends.

• 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: 6085719
• MDR Text Key: 59405061
• Report Number: 0001825034-2016-04530
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 04/13/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• 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): Other