MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR VIVACIT-E 36MM BRNG +3; SHOULDER PROSTHESIS/EXTREMITIES

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374)
Date of Event	06/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical products: item#:110032410 , comp aug mini bsplt w tpr sm; lot #: 64896075.Item#: 110031399, mini tray std cocr +0 offset; item#: 64919666.Item#: 115310, comp rvrs shldr glnsp std 36mm; lot#: 143410.Customer has indicated that the product will not be returned to zimmer biomet for investigation, was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a shoulder arthroplasty and approximately one (1) month later dislocated shoulder.The patient underwent a revision surgery due to the dislocation and disassociation of the implant.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: forward flexed left shoulder with a pop felt in shoulder, stopped pt.Patient experienced dislocation, pain, and loss of function.X-ray identified the glenosphere dissociated from the glenoid baseplate, it was free in the shoulder.Glenoshphere was found in the posterior aspect of the shoulder and there were no complications.A definitive root cause cannot 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CR VIVACIT-E 36MM BRNG +3
• Common Device Name: SHOULDER PROSTHESIS/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12122313
• Report Number: 0001822565-2021-01823
• Device Sequence Number: 17085881
• Product Code: KWS
• UDI-Device Identifier: 00887868231568
• UDI-Public: (01)00887868231568(17)251119(10)64833622
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 11/19/2025
• Device Model Number: N/A
• Device Catalogue Number: 110031425
• Device Lot Number: 64833622
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/31/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR