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

Catalog Number	110031428
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02290.D10: medical products: item#: 110031402, mini tray std cocr +3 offset; lot#: 65666766.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested from the hospital but not returned.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 an initial right shoulder arthroplasty eight months ago with a primary tsa shoulder system.Subsequently, the patient underwent a right shoulder revision surgery approximately three (3) months later due to reoccurring dislocations of the implants that caused instability of the shoulder.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02290-1, 0001822565-2023-02674-1.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (b)(6) 2022: single view right shoulder labeled pre-initial; native bone demonstrates bone on bone appearance of the right glenohumeral joint with likely rotator cuff impingement.(b)(6) 2023: single view right shoulder labeled initial postop demonstrates right reverse tsa with surgical skin staples and soft tissue air consistent with recent surgery.(b)(6) 2023: single view right shoulder labeled pre first revision demonstrates a reverse right tsa with inferior dislocation of the humeral component.(b)(6) 2023: single view right shoulder labeled post first revision demonstrates intact reverse right tsa.Impressions: right reverse tsa with subsequent twice inferior dislocation of the humeral component.No signs of loosening, wear, radiolucency, or any other contributing factor such as malalignment that would cause issues with any of the components on the x-ray.No anatomical or implant deficiencies that would cause/contribute to the recurring instability and need for revision.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 40MM BRNG +3
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/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: 17632367
• Report Number: 0001822565-2023-02289
• Device Sequence Number: 6492223
• Product Code: PHX
• UDI-Device Identifier: 00887868231599
• UDI-Public: (01)00887868231599(17)270915(10)65560677
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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 Catalogue Number: 110031428
• Device Lot Number: 65560677
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female