MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP PRIMARY STEM 12MM MICRO; PROSTHESIS, EXTREMITIES

Model Number N/A

Device Problems Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Adhesion(s) (1695); Rheumatoid Arthritis (1724); Erosion (1750); Unspecified Infection (1930); Scar Tissue (2060); Subluxation (4525); Muscle/Tendon Damage (4532)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: catalog#: xl-115364 arcom xl 44-36 std +3 hmrl brg lot#: 566710; catalog#: 115370 comp rvs tray co 44mm lot#: 687960; catalog#: 01.04440.074 taper s deg 15 lot#: 2977720; catalog#: 01.04440.021 dpsc screw 3.5/4.5x21mm lot#: 2995206; catalog#: 01.04441.068 glenosphere dia 36 deg 15 lot#: 2997068; catalog#: 01.04440.001 baseplate xs 15mm lot#: 2998676.Foreign: (b)(6).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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: 0001825034-2021-00548, 0001825034-2021-00549.

Event Description

It was reported that the patient underwent a revision procedure approximately 1 year and 2 months post implantation due to infection.During the revision, extensive adhesions/scar tissue, rotator cuff damage, stress shielding, and loosening of the humeral and glenoid components were noted.All components were removed, and an antibiotic cement spacer was placed.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.Reported event was confirmed by review of medical records and radiographs received.Review of the available records identified septic loosening of the glenosphere, pseudarthrosis spina scapulae, rheumatoid arthritis.Abundant scar tissue (fibrin), granulation tissue, and pseudomembranes removed.Rotator cuff completely absent from cranial heads.Subluxation of the humeral component and very loose, glenosphere shows movement but is still fixed to the scapula by one of the screws and rotated around the baseplate.Cultures obtained in suspected chronic low-grade infect.Proximal shaft heavily thinned by stress shielding and is fused to the implant.Difficulty removing the humeral implant due to adhesions, window created in the humerus to free the implant, explanted without further complication.Significant glenoid bone defect noted upon removal of the glenosphere and baseplate.Vancomycin treated pmma cement spacer placed.Humeral window closed with a 1.1mm cerclage wire.No confirmation of implant fracture dictated.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: COMP PRIMARY STEM 12MM MICRO
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11361156
• MDR Text Key: 233263943
• Report Number: 0001825034-2021-00550
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K060692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 113612
• Device Lot Number: 191420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention