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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVS CNTRL SCREW 6.5X30MM ST PROSTHESIS, SHOULDER

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BIOMET ORTHOPEDICS COMP RVS CNTRL SCREW 6.5X30MM ST PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problems Screw; Break; Fracture
Event Date 11/03/2014
Event Type  Injury  
Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur: "intraoperative or postoperative bone fracture and/or postoperative pain. " "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight. ".

 
Event Description

Legal counsel for patient reported that patient underwent total reverse shoulder arthroplasty and a subsequent revision procedure on (b)(6) 2014 due to patient allegations of pain and fractured screw. Patient's legal counsel further reported that a portion of the fractured screw allegedly remains in the patient. A review of invoice history revealed that the initial procedure took place on (b)(6) 2012 and confirmed the revision surgery date. This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified. Additional information provided in patient medical records indicates that the revision procedure was performed due to glenoid loosening as a result of a fractured central screw in the baseplate. Medical records further indicate that all components except the humeral stem were removed and replaced. There is no indication in the revision operative report that any portion of the fractured screw was left in the patient.

 
Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. This report is number 1 of 9 mdr's filed for the same event (reference 1825034-2015-01365-2 / 2015-00568 / 2015-00571 / 2015-00572 / 2015-00573 / 2015-00574 / 2015-00575 / 2015-00576 / 2015-00577). Not returned by attorney.

 
Event Description

Legal counsel for patient reported that patient underwent total reverse shoulder arthroplasty and a subsequent revision procedure on (b)(6) 2014 due to patient allegations of pain and fractured screw. Patient's legal counsel further reported that a portion of the fractured screw allegedly remains in the patient. A review of invoice history revealed that the initial procedure took place on (b)(6) 2012 and confirmed the revision surgery date. This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified. Additional information provided in patient medical records indicates that the revision procedure was performed due to glenoid loosening as a result of a fractured central screw in the baseplate. Medical records further indicate that all components except the humeral stem were removed and replaced. There is no indication in the revision operative report that any portion of the fractured screw was left in the patient. Additional information received from patient's legal counsel reported that on (b)(6) 2014, patient experienced gradual onset of pain reported and x-ray indicated that the central screw had fractured and the baseplate had shifted. It was further reported that on (b)(6) 2015, patient underwent an aspiration procedure due to irritated swollen area. On (b)(6) 2015, the surgical site burst open and wept a discolored fluid during therapy session. Subsequently, patient underwent an irrigation and debridement procedure on (b)(6) 2015. A culture taken confirmed bacterial infection. Patient was revised again on (b)(6) 2015 due to deep infection. During the procedure, the patients shoulder was fused with cement spacers. On (b)(6) 2015 patient was taken to the hospital for an allergic reaction to the coating on the spacers.

 
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Brand NameCOMP RVS CNTRL SCREW 6.5X30MM ST
Type of DevicePROSTHESIS, 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 Key4665627
Report Number0001825034-2015-01365
Device Sequence Number1
Product CodePAO
Report Source Manufacturer
Source Type Other,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup
Report Date 01/26/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number115382
Device LOT Number628380
OTHER Device ID NumberN/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 Received01/26/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/23/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/07/2015 Patient Sequence Number: 1
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