MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR VIVACIT-E 40MM BRNG STD; PROSTHESIS SHOULDER

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	12/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: catalog #: 110030777, cr 40mm glenosphere +3mm cocr, lot # 64416228; catalog #: 010000589, comp rvrs 25mm bsplt ha+adptr, lot # 463950; catalog #: 115397, comp rvs cntrl 6.5x35mm st/rst, lot # 417920; catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 324240; catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 216930; catalog #: 180555, comp lk scr 3.5hex 4.75x40 st, lot # 257410; catalog #: 180554, comp lk scr 3.5hex 4.75x35 st, lot # 044220; catalog #: 405889, comp rvs 2.7mm dia drl, lot # 122470; catalog #: 405883, comp rvs 3.2mm drl, lot # 180520; catalog #: 110031399, mini tray std cocr +0 offset, lot # 64873939; catalog #: 113635, comp primary stem 15mm mini, lot # 64488930.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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: 0001822565-2021-00392.Product location unknown.
Event or Problem Description
It was reported that patient underwent left reverse total shoulder arthroplasty approximately 9 weeks ago.Subsequently, patient went in for follow up visit and x-rays showed joint dislocation.Patient underwent revision procedure about 2 weeks later for pain and dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.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 STD
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11331778
• Report Number: 0001822565-2021-00393
• Device Sequence Number: 16402606
• Product Code: KWS
• UDI-Device Identifier: 00887868231582
• UDI-Public: (01)00887868231582(17)250131(10)64597881
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 110031427
• Device Lot Number: 64597881
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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 Weight: 145