MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR 40MM GLENOSPHERE STD COCR; PROSTHESIS, SHOULDER

Catalog Number	110030776
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Procode: phx.Concomitant medical products: bearing standard 40 mm diameter cat# 110031427 lot# 65255407.Report source: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2022 - 02867.
Event or Problem Description
It was reported that a patient was revised approximately 1 month post implantation due to dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10 h6 component code: mechanical (g04) ¿ head no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: final report received from mmi and attached within cmp.Per report there is a dislocation with superior displacement of the humeral implant in relation to the glenosphere.Implant fit appears maintained and individual components appear in appropriate position.No evidence of lucency or wear.There is no fracture or other radiographic evidence of trauma.Bone quality is very osteopenic.The evaluation of the bearing in relation to the tray would be better seen by mri.No other abnormalities identified.A definitive root cause cannot 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 is available at the time of this report.

• Brand Name: CR 40MM GLENOSPHERE STD COCR
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15536561
• Report Number: 0001822565-2022-02868
• Device Sequence Number: 6168108
• Product Code: PHX
• UDI-Device Identifier: 00887868231254
• UDI-Public: (01)00887868231254(17)320509(10)65430434
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110030776
• Device Lot Number: 65430434
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male