MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP REVERSE SHOULDER SHYSTEM VIVACIT-E HIGHTLY CROSSLINKED POLY BEARING; EXTREMITIES IMPLANTS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a shoulder arthroplasty approximately 3 months ago.Patient was revised of previous srs rsa.Patient has dislocated anteriorly some time ago, and has presented to the hospital for follow up with the surgeon.Surgeon attempted a closed reduction with no success, and a surgery date was set.Patient has been described as unhealthy and non-compliant during rehab.During revision surgery, the total construct was unable to be reduced, so the mini humeral tray and poly were removed and replaced with a smaller height total construct, without revision of any humeral stem components or glenoid components.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: unknown, glenosphere, lot # unknown.Catalog #: 110031400, mini tray +5mm cocr +0 offset, lot # 65765542.G2: australia.H3: 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: 0001822565-2023-03414 h3 other text : not returned.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as the reported event is confirmed as the event was reported as non-compliance.Device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to patient non-compliance.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: COMP REVERSE SHOULDER SHYSTEM VIVACIT-E HIGHTLY CROSSLINKED POLY BEARING
• Common Device Name: EXTREMITIES IMPLANTS
• 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: 18265921
• Report Number: 0001822565-2023-03413
• Device Sequence Number: 7757010
• Product Code: KWS
• UDI-Device Identifier: 00887868231568
• UDI-Public: (01)00887868231568(17)280128(10)65592709
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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 Model Number: N/A
• Device Catalogue Number: 110031425
• Device Lot Number: 65592709
• Was Device Available for Evaluation?: No
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Female