MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN BIOMET SHOULDER STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Scratched Material (3020)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Wiater, j.Michael (2017) "exploring failure of total shoulder arthroplasty systems through implant retrieval, radiographic, and clinical data analyses" journal of shoulder and elbow arthroplasty, volume 1: 1¿10.Unknown if bio-modular or comprehensive shoulder system.Initial reporter - the article was written by drew d moore, md, james e moravek, md, erin a baker, phd, meagan r salisbury, ms, kevin c baker, phd and j michael wiater, md at hospitals/universities department of orthopaedic surgery, beaumont health, royal oak, michigan department of surgery, oakland university william beaumont school of medicine, rochester, michigan, department of orthopaedic research, beaumont health, royal oak, michigan.The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.Both legacy biomet and legacy zimmer, along with competitor products, are mentioned in this journal article.It is unclear which complications are tied to what systems.Please see associated reports:0001825034-2017-04286, 0001825034-2017-04288, 0001825034-2017-04290, 0001822565-2017-04408, 0001822565-2017-04407.

Event Description

It was reported in a journal article that among thirty-five (35) shoulder stems retrieved during unknown shoulder arthroplasty revisions, scratching and grooving was noted on an unknown number (approximately 25-30% of the cases).Average length of time the component was implanted was sixty-eight (68) months.Attempts have been made to obtain additional information however further information is not available at this time.

• Brand Name: UNKNOWN BIOMET SHOULDER STEM
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6662914
• MDR Text Key: 78250529
• Report Number: 0001825034-2017-04288
• Device Sequence Number: 1
• Product Code: KWS
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2017
• 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