MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR SRS MOD STEM - 6X75MM; SHOULDER, PROSTHESIS

Catalog Number	211230
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.
Event or Problem Description
It was reported patient is being considered for a revision due to unknown reasons.No revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable.
Event or Problem Description
It was reported that the patient is being considered for a revision due to humeral loosening.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a3, b1, b3, b4, b5, b7, d2, d6, g1-2, g3, g7, h1, h2, h6, h10.Proposed annex g code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: faint radiolucency along the humeral implant as noted which may be loose.Regarding alignment, there is slight humeral stem angulation as noted.Bone quality appears mildly osteopenic.The reported event is confirmed by mmi review.Root cause was unable to 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.

• Brand Name: COMPR SRS MOD STEM - 6X75MM
• Common Device Name: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• 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 ; 5745260384
• MDR Report Key: 17388146
• Report Number: 0001825034-2023-01715
• Device Sequence Number: 3177199
• Product Code: JDC
• UDI-Device Identifier: 00880304507791
• UDI-Public: (01)00880304507791(17)291203(10)243250
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023
• 2 Devices were Involved in the Event: 1 2

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: 211230
• Device Lot Number: 243250
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2019
• 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 Age: 22 YR
• Patient Sex: Female