MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHDR GLEN BSPLT +HA; PROSTHESIS, EXTREMITIES

Model Number	N/A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: item# 115310; comp rvrs shldr glnsp std 36mm; lot# 010830; item# 115395; comp rvs cntrl 6.5x25mm st/rst; lot# 065080; item# 180552; comp lk scr 3.5hex 4.75x25 st; lot# 630460; item# 180551; comp lk scr 3.5hex 4.75x20 st ; lot# 701060; item# 180559; comp nlk scr 3.5hex 4.75x25 st; lot# 694610; item# 118001; versa-dial/comp ti std taper pr adaptor; lot# 248840; item# xl-115363; arcom xl 44-36 std hmrl brng; lot# 189310; item# 115370; comp rvs tray co 44mm; lot# 713450; item# 113633; comp primary stem 13mm mini m mini; lot# 713450.Report source: foreign: event occurred in (b)(6).The product will not be returned to zimmer biomet for investigation.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: 0001825034-2020-01528, 0001825034-2020-01530.Product not returned.
Event or Problem Description
It was reported the patient underwent a revision procedure two days post-implantation due to detachment of the glenosphere causing the shoulder to dislocate.During the revision, the surgeon checked the central screw and found it was not seated properly and may have caused the glenosphere to detach.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Reported event was confirmed as it was found during revision that the central screw was not seated well which led to disassociation.Device history record was reviewed and no discrepancies were found.As per surgical technique, it was stated that ¿to verify the central screw is fully seated in the baseplate, a check with the central screw drill guide should be performed.A fully seated central screw provides the best compression and fixation, as well as ensures the male taper of the glenosphere will fully engage.As a drill guide was not present in the initial surgery, the root cause is determined to be user error.A summary of the investigation has been sent to the complainant.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: COMP RVRS SHDR GLEN BSPLT +HA
• Common Device Name: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9969201
• Report Number: 0001825034-2020-01500
• Device Sequence Number: 2282428
• Product Code: KWS
• UDI-Device Identifier: 00880304475342
• UDI-Public: (01)00880304475342
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: 115330
• Device Lot Number: 903630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 95