MAUDE Adverse Event Report: ZIMMER CAS PSI SHOULDER TM GLENOID LT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision six(6) years post implantation due disassociation and pain.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The device was not returned to the product surveillance team.A physical evaluation and technical review was not possible.Dhr review shows no anomalies ordeviations that would have affected the surgical outcome or contributed to the reported event.Per the surgeon report, no complications with the psi guide were experienced during the initial procedure.'once we had adequate exposure, the psi guide was affixed anteriorly and located.A coracoid pin was placed and a second pin was placed for the cannulated reamer.This was slightly more anterior, and therefore 9 cannulated design was selected.A drill hole was made centrally, and then the reamer was sued with the appropriate reamer stop for the trabecular metal glenoid.The drill holes and box cut were made without difficulty.A 40-mm glenoid with a 46mm radius curvature was then impacted into position.An excellent glenoid fixation was obtained.' further, the report states 'no complications.Prognosis was good.' further, xray images were provided and analyzed by a third party.Per the mmi report, a large glenoid defect noted along the superior aspect of the glenoid appears to relate to the fractured glenoid component.A definitive root cause is unable to be determined with the information available.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.

• Brand Name: PSI SHOULDER TM GLENOID LT
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer (Section G): ZIMMER CAS; 75 queen str.; suite 3300; montreal, quebec H3C 2 N6; CA H3C 2N6
• Manufacturer Contact: kristen lashley ; 56 e. bell dr.; warsaw, IN 46582 ; 9016334069
• MDR Report Key: 16995215
• Report Number: 0009617840-2023-00008
• Device Sequence Number: 16988492
• Product Code: KWT
• UDI-Device Identifier: 00889024304130
• UDI-Public: (01)00889024304130(17)160307(10)63178536
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2023

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: 03/07/2016
• Device Model Number: N/A
• Device Catalogue Number: 20807500401
• Device Lot Number: 63178536
• 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: 11/26/2022
• Initial Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• 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 Age: 79 YR
• Patient Sex: Female