MAUDE Adverse Event Report: ZIMMER CAS COMPR AUG SHLDR GD AND BN R; SHOULDER ARTHROPLASTY IMPLANTATION SYSTEM

Model Number	N/A
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a personalized shoulder guide used in a shoulder replacement surgery was built with excessive inferior tilt.14 weeks following the surgery the patient was still struggling to get motion in forward flexion/abduction past 90 degrees.At the time of this report submission there is no surgical intervention planned.Attempts have been made and no further information has been provided at this time.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a personalized shoulder guide used in a shoulder replacement surgery was built with excessive inferior tilt.14 weeks following the surgery the patient was still struggling to get motion in forward flexion/abduction past 90 degrees.At the time of this report submission there is no surgical intervention planned.Attempts have been made and no further information has been provided at this time.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).This follow-up report is being submitted to relay additional information.Technical review and physical evaluation a physical evaluation was not possible as the product was not returned for investigation.An sme analysis was conducted comparing the cad models and surgeon planning report for this patient.Cad models for the relevant patient¿s bone model and pin guide were assessed to verify that the baseplate inclination angle obeyed what the surgeon in the surgical planning report specified.The baseplate inclination angle of the personalized shoulder pin guide was consistent with the angle specified in the surgical planning report with no differences observed.Dhr was reviewed and no discrepancies related to the reported event were found.A complaint history search was conducted : the search identified no additional similar complaints reported for this part number within one (1) year prior to the notification date of this complaint and thereafter for the same or similar issue.A definitive root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPR AUG SHLDR GD AND BN R
• Common Device Name: SHOULDER ARTHROPLASTY IMPLANTATION SYSTEM
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13941173
• Report Number: 0009617840-2022-00012
• Device Sequence Number: 11881203
• Product Code: KWT
• UDI-Device Identifier: 00889024563407
• UDI-Public: (01)00889024563407(10)65239580
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K190595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 20-8090-004-02
• Device Lot Number: 65239580
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• 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: Disability
• Patient Sex: Female