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

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374)

Event Type  Injury  

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.The following could not be completed with the limited information provided.Date of event - unknown brand name - unknown device product code - unknown device info- unknown date implanted - unknown date explanted - unknown (b)(6).The 510k number - unknown.Manufacture date ¿ unknown.This report is 1 of 2 mdrs filed for the same article (reference 1825034-2016-00756 & 3006946279-2016-00011).

Event Description

Information was received based on review of a journal article titled, "total shoulder arthroplasty: are the humeral components getting shorter?" which aimed to examine shortening of the humeral component or eliminating the stem entirely to rely on stemless fixation in the humeral metaphysis.The short stem study consisted of three (3) separate studies: e.Atoun reported thirty-four (34) patients with the verso humeral component who were followed for at least 24 months.Patients ranged between the ages of 58 and 93 years.Pw jost reported forty-nine (49) patients with anatomic comprehensive mini humeral components which were followed for at least 24 months.Patients ranged between the ages of 59 and 92 years.Sa giuseffi reported forty-four (44) patients with reverse total shoulders performed using comprehensive mini stems with a last 24-months follow up.Patients ranged between the ages of 46 and 83 years.The journal article reported the following results: sa giuseffi study reported 97% of the patients had no pain or only mild pain.The complications reported were two (2) varus stems, one (1) dislocation, thirteen (13) proximal humerus resorption, one (1) brachial plexus palsy, one (1) superficial infection.The pw jost study reported one (1) subscapularis rupture, one (1) pe, five (5) varus stems.The e.Atoun study reported two (2) dislocations, two (2) metaphyseal fracture, forty-one (41) glenoid fractures, one (1) acromion stress fracture, one (1) glenoid periprosthetic fracture and four (4) metaphyseal periprosthetic fractures.The authors of this article conclude that there are advantages of a shorter stem, including preserved bone stock, less stress shielding, eliminating the diaphyseal stress riser, ease of stem removal at revision, and humeral head placement independent from the humeral shaft axis.However, it is not clear how or when these implants may fail.Future clinical trials are necessary for more robust conclusions.

Manufacturer Narrative

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

Event Description

Information was received based on review of a journal article titled, "total shoulder arthroplasty: are the humeral components getting shorter?" which aimed to examine shortening of the humeral component or eliminating the stem entirely to rely on stemless fixation in the humeral metaphysis.Two (2) separate studies involved biomet's nano shoulder system and comprehensive mini shoulder system.(b)(4) reported forty-nine (49) patients with anatomic comprehensive mini humeral components which were followed for at least 24 months.Patients ranged between the ages of 59 and 92 years.(b)(4) reported forty-four (44) patients with reverse total shoulders performed using comprehensive mini stems with a last 24-months follow up.Patients ranged between the ages of 46 and 83 years.The journal article reported the following results: (b)(4) study reported 97% of the patients had no pain or only mild pain.The complications reported were two (2) varus stems, one (1) dislocation, thirteen (13) proximal humerus resorption, one (1) brachial plexus palsy, one (1) superficial infection.The (b)(4) study reported one (1) subscapularis rupture, one (1) pe, five (5) varus stems.The authors of this article conclude that there are advantages of a shorter stem, including preserved bone stock, less stress shielding, eliminating the diaphyseal stress riser, ease of stem removal at revision, and humeral head placement independent from the humeral shaft axis.However, it is not clear how or when these implants may fail.Future clinical trials are necessary for more robust conclusions.

• Brand Name: UNKNOWN SHOULDER
• 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: 5480837
• MDR Text Key: 39697070
• Report Number: 0001825034-2016-00756
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2016
• 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