MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS CNTRL 6.5X25MM ST/RST; 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
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog#: 110032410, comp aug mini bsplt w tpr sm, lot# 64274365, catalog#: 113629, comp primary stem 9mm mini, lot# 64559055, catalog#: 110031399, mini tray std cocr +0 offset, lot# 64855962, catalog#: 110031424, cr vivacit-e 36mm brng std, lot# 64833586, catalog#: 115310, comp rvrs shldr glnsp std 36mm, lot# 396310, 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.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.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: 0001822565-2023-00204, 0001825034-2023-00148, 0001825034-2023-00149, 0001825034-2023-00150, 0001825034-2023-00151.
Event or Problem Description
It was reported that the patient had initial left total shoulder arthroplasty approximately 2 years ago.Then, about 5 months later the patient reported pain.Ct and x-rays revealed acromial stress fracture healing, superior tilt, scapular notching, loosening of the baseplate, and failure of the reverse baseplate.Two months later an aspiration ruled out infection.A 2 stage revision was planned to place spacers to obtain proper imaging for vrs of worn glenoid.Subsequently the first stage revision was delayed due to dental work.Consequently, 4 months later the 1st stage revision noted stem well intact and remained implanted, switching the revision to a hemiarthroplasty without spacers.The glenoid was loose and exchanged.Then, about 5 months later the 2nd stage revision of hemi to reverse tsa with vrs was completed.No operative records provided.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Updated: b4, b5, g3, h1, h2, h3, h6, h10.Reported event was confirmed as ct scans showed acromial stress fracture healing and x-rays noted superior tilt, scapular notching, loosening of the baseplate, and failure of the reverse baseplate.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: COMP RVS CNTRL 6.5X25MM ST/RST
• Common Device Name: EXTREMITIES IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16241908
• Report Number: 0001825034-2023-00147
• Device Sequence Number: 17797858
• Product Code: KWS
• UDI-Device Identifier: 00880304677074
• UDI-Public: (01)00880304677074(17)301008(10)072000
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• 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,Followup
• Report Date (Section B): 02/22/2023

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 Model Number: N/A
• Device Catalogue Number: 115395
• Device Lot Number: 072000
• 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
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Female