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

Catalog Number 118001

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); Reaction (2414); Osteopenia/ Osteoporosis (2651)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00842.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information 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

It was reported that the patient had a reverse total shoulder approximately 7 years ago.Patient complained of pain and lack of range of motion.The glenosphere had disengaged from the standard baseplate and was free floating in the patients joint.While performing the revision surgery, surgeon noticed that there was a small amount of metallosis in the patient's joint.After the surgery, surgeon further stated that the components were malpositioned.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned taper identified heavy wear.Insufficient information provided.Unable to perform a compatibility check.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: the glenosphere component has been disassembled, there is resultant dislocation of the humeral component.Bones are osteopenic.Review of the device history record(s) identified no deviations or anomalies during manufacturing for taper.A definitive root cause cannot be determined.The per from the sales rep mentions malpositioning of the components by the surgeon, however, this could not be confirmed.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, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9756377
• MDR Text Key: 189216988
• Report Number: 0001825034-2020-00841
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00880304217249
• UDI-Public: (01)00880304217249
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

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 Expiration Date: 03/22/2023
• Device Catalogue Number: 118001
• Device Lot Number: 081850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: GLENOSPHERE CATALOG#: 115310 LOT#: 161780; UNKNOWN BASEPLATE; UNKNOWN HUMERAL BEARING; UNKNOWN HUMERAL TRAY
• Patient Outcome(s): Hospitalization; Required Intervention