MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR VIVACIT-E 40MM BRNG +3; PROSTHESIS EXTREMITIES

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 110030776, cr 40mm glenosphere std cocr, lot # 65323728.Catalog #: 110030776, 40mm versa-dial glen std, lot # 65323728.Catalog #: 118000, 25mm versa-dial taper adaptor, lot # 909850.Catalog #: 110031400, hmrl tray std +5, lot # 65255146.Catalog #: 115395, comp rvs cntrl 6.5x25mm, lot # 182630.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02230.
Event or Problem Description
It was reported that patient had an initial surgery on an unknown date.Subsequently, about 2 weeks ago the patient was revised due to the glenosphere being dislocated.It was stated that there is also significant wear on the humeral poly.
Event or Problem Description
It was further reported that the patient underwent a revision approximately 7 months post initial implantation.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as visual examination of the returned products identified that the glenosphere, a taper adapter, a screw and a poly bearing were returned.There is damage noted on the glenosphere, bearing, and the tray.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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: CR VIVACIT-E 40MM BRNG +3
• Common Device Name: PROSTHESIS EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15114613
• Report Number: 0001822565-2022-02229
• Device Sequence Number: 12230913
• Product Code: KWS
• UDI-Device Identifier: 00887868231599
• UDI-Public: (01)00887868231599(17)260913(10)65163939
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2026
• Device Model Number: N/A
• Device Catalogue Number: 110031428
• Device Lot Number: 65163939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male