MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP PRIMARY STEM 11MM MINI; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Stenosis (2263); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/11/2015

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Medical product ¿ versa-dial 50x21x57 hum head, cat#: 113053 lot#: 920440; md hybrid glenoid base 4mm, cat#: 113954 lot#: 019410; pt hybrid glen post regenerex, cat#: pt-113950 lot#: 195880; versa dial/comprehensive std t pr adaptor, cat#: 118001 lot#: 603610; cobalt hv bone cement 40g, cat#: 402282 lot#: 780720; optivac kit 40gram single mix, cat#: 417100 lot#: 698023; 1/8 quick rel drl sterile 2pk, cat#: 32-486265 lot#: 357110; gps iii single kit w/30ml acda, cat#: 800-1003a lot 069871; biomet biologics spray kit, cat#: 800-0250 lot#: 109501; gps dual spray applicator tip, cat#: 800-0201 lot#: 107511.Customer has indicated that the product will not be returned (as it remains implanted) 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: 1825034-2017-01417 ¿ 01421.

Event Description

It was reported that the patient is in need of a left shoulder revision due to a mass and dislocation which has led to lumbar stenosis and the inability to ambulate approximately 5 years post-implantation.However, the surgeon has stated that the patient's health is too poor to undergo the revision.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Device was not returned for analysis; therefore, a product evaluation could not be conducted.Dhrs were reviewed and no discrepancies were found.Review of the complaint histories determined that no further action is required as no were trends identified.Root cause was undetermined.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: COMP PRIMARY STEM 11MM MINI
• 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: 6386862
• MDR Text Key: 69338928
• Report Number: 0001825034-2017-01417
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 113631
• Device Lot Number: 652380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2007
• 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): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 113