MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR VIVACIT-E 36MM BRNG STD; EXTREMITIES IMPLANTS

Model Number	N/A
Medical Device Problem Codes	Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Erosion (1750); Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994)
Date of Event	12/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had initial left total shoulder arthroplasty approximately two (2) years ago.Then, about five (5) months later the patient reported pain.Computerized tomography (ct) and radiographs revealed acromial stress fracture healing, superior tilt, scapular notching, loosening of the baseplate, and failure of the reverse baseplate.Two months later, an aspiration was conducted and ruled out infection.A 2-stage revision was planned to place spacers to obtain proper imaging for implants of worn glenoid.Subsequently the first stage revision was delayed due to patient.Consequently, four (4) months later the 1st stage revision was conducted, and the surgeon noted the stem was well fixed and the surgeon opted to keep the stem implanted.Therefore, the surgeon switched the revision to a hemiarthroplasty without spacers.The glenoid was loose and exchanged.Then, about five (5) months later the 2nd stage revision of hemiarthroplasty to a reverse total shoulder arthroplasty was completed.No operative records provided.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Medical products: catalog #: 113629, comp primary stem 9mm mini, lot # 64559055; catalog #: 110031399, mini tray std cocr +0 offset, lot # 64855962; catalog #: 115310, comp rvrs shldr glnsp std 36mm, lot # 396310; catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 230770; catalog #: 115395, comp rvs cntrl 6.5x25mm st/rst, lot # 072000; catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 635280; catalog #: 180551, comp lk scr 3.5hex 4.75x20 st, lot # 348370; catalog #: 180550, comp lk scr 3.5hex 4.75x15 st, lot # 380320; catalog #: 110032410, comp aug mini bsplt w tpr sm, lot # 64274365.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested but not returned by the hospital.Reported event was unable to be confirmed as no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of manufacturing records is not required as the reported pain has been attributed to the loosening and scapular notching and will be reflected in the linked complaint.These issues were seen in the ct scan and x-rays.The root cause of the reported issue is attributed to not device related as the reported pain is attributed to loosening and scapular notching which are being investigated through the implants on the linked complaint.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.Multiple mdr reports were filed for this event: 0001822565-2023-00204, 0001825034-2023-00147, 0001825034-2023-00148, 0001825034-2023-00149, 0001825034-2023-00150, 0001825034-2023-00151, 0001825034-2023-00189, and 0001825034-2023-00190.

• Brand Name: CR VIVACIT-E 36MM BRNG STD
• 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: 16282862
• Report Number: 0001822565-2023-00247
• Device Sequence Number: 20088598
• Product Code: KWS
• UDI-Device Identifier: 00887868231315
• UDI-Public: (01)00887868231315(17)300817(10)64855962
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2023

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 Expiration Date: 09/27/2025
• Device Model Number: N/A
• Device Catalogue Number: 110031424
• Device Lot Number: 64833586
• 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: 07/19/2022
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female