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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Nerve Damage (1979); Pain (1994)

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.(b)(4).The following could not be completed with the limited information provided.Date of event ¿ ni, device product code ¿ ni, expiration date ¿ ni, date implanted ¿ ni, date explanted ¿ ni, initial reporter - the article was written by culp, randall w.; bachoura, abdo; gelman, scott e.; and jacoby, sidney m., manufacture date ¿ ni.

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.Seventeen (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) female with a history of posttraumatic arthritis underwent right wrist arthroplasty.Patient subsequently experienced wrist stiffness, pisotriquetral arthritis, ulnar tunnel syndrome, and extensor tenosynovitis of the small finger.Patient was treated with capsulectomy, pisiformectomy, ulnar tunnel release, and steroid injection, respectively.At the 26 month follow-up, patient reported pain.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: 6367820
• MDR Text Key: 68659985
• Report Number: 0001825034-2017-01263
• 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: Other
• Type of Report: Initial
• Report Date: 03/01/2017

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
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR