MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP RVRS SHLDR GLNSP STD 36MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 11/19/2014

Event Type  Injury  

Event Description

It was reported patient underwent a right comprehensive reverse total shoulder arthroplasty on an unknown date.Subsequently, the patient was revised on (b)(6) 2014 due to dislocation.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.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 1 of 2 mdrs filed for the same event (reference 1825034-2014-09038 / 09039).

Manufacturer Narrative

The returned components were evaluated and found to have been manufactured within specifications.Visual examination revealed excessive wear.It was believed the initial procedure left the humeral and glenoid components misaligned causing a dislocation issue and improper product wear.Without data on the initial procedure this is the observation from the surgeon doing the revision only.

• Brand Name: COMP RVRS SHLDR GLNSP STD 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4322378
• MDR Text Key: 15316551
• Report Number: 0001825034-2014-09038
• 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: 01/12/2015

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: 115310
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 12/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 60 YR