MAUDE Adverse Event Report: ZIMMER BIOMET, INC. Comprehensive® Reverse Shoulder; shoulder prosthesis, reverse configuration

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Codes	Scar Tissue (2060); Joint Dislocation (2374); Subluxation (4525)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: ref ti-115320, lot 214900, titanium glenosphere.Ref 118001, lot 225630, taper adaptor.Ref xl-115366, lot 157810, humeral bearing.Ref 115340, lot 259660, humeral tray.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location is unknown.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: 0001825034-2020-00715.
Event or Problem Description
It was reported patient underwent a revision reverse total shoulder arthroplasty.Subsequently, the patient underwent a second revision approximately one year post revision due to subluxation.The stem and baseplate remained intact while the tray, bearing, and glenosphere were replaced.
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/corrected updated: h2; h3; h6.Reported event was confirmed by review of medical records received.Review of the available records identified diagnoses indicated luxation of the left glenosophere.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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.
Event or Problem Description
It was reported that the patient underwent a revision of a left reverse total shoulder arthroplasty due to subluxation.It was reported that the glenosphere had dislocated.During the revision, the polyethylene insert was reported to show partial wear and was removed, and overgrowth of scar tissue at the glenoid baseplate was removed.The glenoid baseplate was reported to be integrated and was retained, and a replacement glenosphere was secured to it.The humeral cup was reported to be well fixed, and when the insert could not be placed without difficulty the humeral cup was removed and its taper was reported to be altered.The glenosphere, taper adaptor, humeral bearing and humeral tray were reported to have been explanted and replaced, and the humeral stem was retained.The components were reported to provide good range of motion and to be stable and well fixed, and closure was reported without complications.Due diligence is complete for this complaint; it was reported that no further information is available, and to date no additional information or product has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products in the d10 narrative below.D10: concomitant medical products, part (lot): - ti-115320 (214900) - 115340 (259660) associated product information: - 118001 (225630) - 115330 (786740) all sections have been updated.The prior submissions for this event were filed on the form version and field conventions in effect at that time.This report is prepared on the current version of the form: information previously carried in the narrative, or not collected as a structured field at that time, is now entered in the corresponding form fields, and codes are taken from the code release current at submission.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

• Brand Name: Comprehensive® Reverse Shoulder
• Common Device Name: shoulder prosthesis, reverse configuration
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• 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 ; +1(574)526-0384
• MDR Report Key: 9710884
• Report Number: 0001825034-2020-00716
• Device Sequence Number: 16795002
• Product Code: PHX
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2026

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: Lay User/Patient
• Device Expiration Date: 12/16/2021
• Device Model Number: N/A
• Device Catalogue Number: XL-115366
• Device Lot Number: 157810
• 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: 01/31/2020
• Supplement Date Received by Manufacturer: 08/03/2020; 07/02/2026
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 08/04/2020; 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male