MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVSR SHLDR GLNSP +3 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 05/01/2014

Event Type  Injury  

Event Description

It was reported that patient underwent a reverse shoulder procedure on (b)(6) 2010.Subsequently, a revision procedure was performed on (b)(6) 2014 due to dislocation.The humeral bearing and humeral tray were removed and replaced.

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 9 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity or excessive activity can also contribute to these conditions." this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-04980 & 04981).

Manufacturer Narrative

Examination of returned device was inconclusive.Insufficient information to determine failure mode or root cause.The components do not appear to have been implanted as the articulating surface and face of the bearing show no signs of contact with the mating surfaces nor does the taper show sign of impaction.

Event Description

It was reported that patient underwent a reverse shoulder procedure on (b)(6) 2014.Subsequently, a revision procedure was performed on (b)(6) 2014 due to dislocation.The humeral bearing and humeral tray were removed and replaced.

• Brand Name: COMP RVSR SHLDR GLNSP +3 36MM
• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3839373
• MDR Text Key: 21731117
• Report Number: 0001825034-2014-04981
• Device Sequence Number: 1
• Product Code: PAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2014

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 Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 115313
• Device Lot Number: 682080
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2014
• Initial Date FDA Received: 05/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2014
• 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: 76 YR