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

Model Number N/A

Device Problems Device Slipped (1584); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 10/27/1999

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 left total shoulder arthroplasty on an unknown date.Subsequently, a revision procedure was performed on (b)(6) 1999 due to pain and a rotator cuff disruption.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 and product identification was not provided for the patients mentioned in the journal article.Initial reporter -the article was written by nahum rosenberg, lars neumann, amit modi, istvan j mersich and angus w wallace; bmc musculoskeletal disorders 2007, 8:76 doi:10.1186/1471-2474-8-76; and this article is available from: http://www.Biomedcentral.Com/1471-2474/8/76.(b)(6).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: 4409166
• MDR Text Key: 5165376
• Report Number: 0001825034-2015-00095
• 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

• 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
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 01/12/2015
• 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): Required Intervention
• Patient Age: 74 YR