MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL/COMP TI STD TAPER; PROSTHESIS, SHOULDER

Catalog Number 118001

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi#: (b)(4).Concomitant medical products: 115313 comp rvsr shldr glnsp 824510, xl-115363 arcom xl 44-36 std hmrl brng ring 380360, 115370 comp rvs tray co 44mm 689110, 110005096 juggerknot 2.9 w/ tapered ndls 814120.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial right shoulder procedure.Subsequently, the patient was revised due to disassociation.No additional patient consequences were reported.

Event Description

It was reported that the patient underwent a right shoulder arthroplasty revision to address disassociation of the glenosphere from the baseplate.Initial operative notes did not identify any intraoperative complications.Revision operative notes identified that the glenosphere, humeral tray and bearing were removed and replaced with no intraoperative complications.No additional patient consequences were reported.

Manufacturer Narrative

The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.Radiographic review identified that the humeral stem and baseplate were well-fixed and aligned, however, the glenosphere had dislodged from the baseplate.The device history records were reviewed and no discrepancies relevant to the reported event were identified.A definitive root cause could not be determined with the information provided.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: VERSA-DIAL/COMP TI STD TAPER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9187021
• MDR Text Key: 162518820
• Report Number: 0001825034-2019-04402
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K060716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 118001
• Device Lot Number: 547120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 82