MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPR SRS IC SEG - 60MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problem Joint Dislocation (2374)

Event Date 02/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product - compr srs anti rot ic seg-30mm, cat#: 211266 lot#: 515410; compr srs mod stem - 10x100mm, cat#: 211237 lot#: 871110; humeral screw kit 2 humeral screws, cat#: 00840009000 lot#: 63425387; articulation kit size 5/6 1 axle pin, 1 humeral bearing a, 2 ulnar bearings b, cat#: 00840009500 lot#: 63396483; compr srs large flange, cat#: 211270 lot#: 231150; elbow torque driver, cat#: 00840108000 lot#: 56613805; compr srs 60mm dst hum bdy lt, cat#: 110029825 lot#: 115510.Therapy date ¿ unknown date in (b)(6) 2017.Customer has indicated that the product will not be returned [as it remains implanted at the time of this report] to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports:1825034-2017-01558 / 01566.

Event Description

It has been reported that the patient underwent a left elbow arthroplasty and approximately 12 days post-implantation the patient stated hearing a clicking sound.Radiographs reveal that the humeral component has failed and separated from the intercalary segment.No revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint x ray¿s were evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.An x-ray was provided and reviewed.The results of the review identified the following: "comprehensive segmental distal humeral/elbow reconstruction prostheses are present.The humeral distal body component is completely dissociated from the humeral stem component, and is displaced medially.A stabilizing plate and screw are not identified in the vicinity of junction of humeral stem and body components." root cause was unable to be determined.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: COMPR SRS IC SEG - 60MM
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6404038
• MDR Text Key: 69915541
• Report Number: 0001825034-2017-01566
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 211225
• Device Lot Number: 104420
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2016
• 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
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR