MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SM HYBRID GLENOID BASE 4MM; PROSTHESIS, SHOULDER

Model Number	113952
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 113951 430510 pc hybrid glen post-poly.113046 634490 versa-dial 46x24x47 hum head.Report source: foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device 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: 0001825034-2021-02463.
Event or Problem Description
It was reported that the patient underwent an initial shoulder arthroplasty.Subsequently, the patient was revised due to the glenoid loosening.No additional patient consequences were reported.
Event or Problem Description
No additional event information is 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, g3, g6, h1, h2, h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies were found.No medical records were provided.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: SM HYBRID GLENOID BASE 4MM
• Common Device Name: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12406463
• Report Number: 0001825034-2021-02465
• Device Sequence Number: 14498490
• Product Code: KWS
• UDI-Device Identifier: 00880304462625
• UDI-Public: (01)00880304462625(17)210513(10)017180
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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 Expiration Date: 05/13/2021
• Device Model Number: 113952
• Device Catalogue Number: 113952
• Device Lot Number: 017180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR