MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN MAESTRO WRIST RADIAL COMPONENT PROSTHESIS, WRIST

Model Number N/A

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Loss of Range of Motion (2032); 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 were not provided for the patient mentioned in the journal article. Initial reporter - the article was written by culp, randall w. ; bachoura, abdo; gelman, scott e. ; and jacoby, sidney m. (b)(4).

Event Description

Information was received based on review of a journal article titled, " proximal row carpectomy combined with wrist hemiarthroplasty " which aimed to present early experience with proximal row carpectomy (prc) combined with distal radius hemiarthroplasty using the maestro wrist reconstructive system radial component, manufactured by legacy biomet from april 2009 to june 2010. A competitor product was used from september 2010 onwards. Approx 17 patients were identified in the article that underwent proximal row carpectomy combined with distal radius hemiarthroplasty with a maestro radial component on an unknown date. Mean postoperative flexion, extension, and grip strength were all less than preoperative levels. It is reported that a (b)(6) male with a history of slac iii wrist underwent right wrist arthroplasty. At the 20 month followup, patient reported pain. At the 26th month followup, radiograph findings included osteolysis of distal carpal bones. The patient was revised for aseptic loosening secondary to poly disease shortly afterward. No further information is available.

• Brand Name: UNKNOWN MAESTRO WRIST RADIAL COMPONENT
• Type of Device: PROSTHESIS, WRIST
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6367736
• MDR Text Key: 68747148
• Report Number: 0001825034-2017-01255
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/03/2017
• 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 Treatment Data

Date Received: 03/01/2017 Patient Sequence Number: 1