MAUDE Adverse Event Report: BIOMET ORTHOPEDICS BI-ANGULAR HUM HD COCR 48X19MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)

Event Date 08/27/2008

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: under possible adverse effects, number 4 states, "dislocation of the bipolar shoulder component has been reported.".

Event Description

It was reported that patient underwent a total shoulder arthroplasty on (b)(6) 2006.Subsequently, patient was revised on (b)(6) 2008 due to dislocation.The proximal body, glenoid tray, bearing, head, and intercalary segment were removed and replaced.Patient was further revised on (b)(6) 2008 due to unknown reasons.The glenoid tray was removed and replaced with a custom component.A third revision procedure has been indicated due to infection; however, no revision procedure has been reported to date.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

It was reported that patient underwent a total shoulder arthroplasty on (b)(6) 2006.Subsequently, patient was revised on (b)(6) 2008 due to dislocation.The proximal body, glenoid tray, bearing, head, and intercalary segment were removed and replaced.Patient was further revised on (b)(6) 2008 due to unknown reasons.The glenoid tray was removed and replaced with a custom component.Additional information received reported that a third revision procedure occurred approximately 6 months ago due to infection.During the procedure, the glenoid and humeral stem were removed, and the procedure was completed with competitor spacers.Patient underwent a reimplantation procedure on (b)(6) 2016.Custom products were used to complete the procedure.

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 3 of 5 mdrs filed for the same event (reference 1825034-2015-03546 / 2015-03547 / 2015-03831 / 2016-01156 / 2016-01159).

Event Description

It was reported that patient underwent a total shoulder arthroplasty on (b)(6) 2006.Subsequently, patient was revised on (b)(6) 2008 due to dislocation.The proximal body, glenoid tray, bearing, head, and intercalary segment were removed and replaced.Patient was further revised on (b)(6) 2008 due to unknown reasons.The glenoid tray was removed and replaced with a custom component.Additional information received reported that a third revision procedure occurred approximately 6 months ago due to infection.During the procedure, the glenoid and humeral stem were removed, and the procedure was completed with competitor spacers.Patient underwent a reimplantation procedure on (b)(6) 2016.Custom products were used to complete the procedure.Additional information received reported that a future revision procedure has been indicated due to dislocation; however, another revision has not been reported at this time.

Manufacturer Narrative

This follow up report is being filed to relay corrected information.

Event Description

Patient's left shoulder was revised approximately 29 months post-implantation due to dislocation.During the procedure, the proximal body, glenoid tray, glenoid bearing, humeral head and humeral intercalary segment were removed and replaced.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BI-ANGULAR HUM HD COCR 48X19MM
• 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: 5032508
• MDR Text Key: 24136106
• Report Number: 0001825034-2015-03831
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK032895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Followup,Followup,Followup,Followup
• Report Date: 05/18/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2015
• Device Model Number: N/A
• Device Catalogue Number: 114024
• Device Lot Number: 566850
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Supplement Dates Manufacturer Received: Not provided; 04/20/2018; 04/20/2018; 04/20/2018
• Supplement Dates FDA Received: 02/18/2016; 04/07/2016; 09/20/2016; 05/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2005
• 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: 52 YR