MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN BIO-MODULAR SHOULDER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 04/10/2002

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "improvements in survival of the uncemented nottingham total shoulder prosthesis: a prospective comparative study¿ which compared the survivorship of three types of uncemented total shoulder arthroplasty prostheses (biomodular, initial nottingham tsr and current nottingham tsr systems).The study was divided into three groups of patients; group 1 consisted of ninety (90) patients who received biomodular tsr between 1989 and 1994, group 2 consisted of one-hundred three (103) patients who received the initial nottingham tsr between 1994 and 1997, group 3 was comprised of thirty-four (34) patients who received the current nottingham tsr between 1998 and 1999.The comparison of the annual cumulative survivorship values in the compatible time range between the three groups was done according to the paired "t" test.A patient was identified in the biomodular group who underwent right total shoulder arthroplasty on an unknown date.Subsequently, a revision procedure was performed on (b)(6) 2002 due to rotator cuff tear with a previous hemiarthroplasty from more than ten years prior.During the revision, the head was exchanged and patient underwent an acromioplasty and rotary cuff plication.There has been no further information provided and the patient outcome is unknown.The above referenced journal article is attached to this medwatch and the manufacturer report number of the medwatch which reports on all patients (identified and non-identified) mentioned in the journal article is 1825034-2014-08061.

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details product identification was not provided for the patients mentioned in the journal article.The following sections could not be completed with the limited information provided.Catalog number, lot number and expiration date - unknown, date implanted - unknown.(b)(6).Manufacture date ¿ unknown.It is likely that the complication for this patient has already been reported; however, it cannot be determined based on the limited patient information made available in the article.Should additional information relating to the patient complication be received, the updated information will be forwarded to the fda.

• Brand Name: UNKNOWN BIO-MODULAR SHOULDER
• Type of Device: PROSTHESIS, SHOULDER
• 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: 4409202
• MDR Text Key: 5165926
• Report Number: 0001825034-2015-00099
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• 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
• 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: 12/18/2014
• 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): Required Intervention
• Patient Age: 85 YR