MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE CENTRIC 36 MM DIAMETER +0 MM LATERAL OFFSET; SHOULDER, PROSTHESIS

Catalog Number	00436003600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised due to the implant disassociation.Glenosphere was removed and replaced.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 02438.D10: unknown baseplate 36mm ã¿ +0mm offset poly liner cat: 00434903600 lot: 65205886.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
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: d6, d10, h4, h6, h10 proposed component code: mechanical (g04) - head d10: base plate uncemented 15 mm post length cat: 00436201500 lot: 65885670.Visual examination of the returned product identified a zimmer tm reverse plus glenosphere was returned.As returned, damage is seen on the buffed surface and taper feature.Dhr shows the taper is inspected 100% on a cmm at the time of manufacture.All devices were found to be conforming to print specifications.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.The reported revision is confirmed from product return, but the reported event of disassociation is not confirmed.

• Brand Name: GLENOSPHERE CENTRIC 36 MM DIAMETER +0 MM LATERAL OFFSET
• Common Device Name: SHOULDER, PROSTHESIS
• 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: 17709893
• Report Number: 0001822565-2023-02439
• Device Sequence Number: 6716881
• Product Code: HSD
• UDI-Device Identifier: 00889024489479
• UDI-Public: (01)00889024489479(17)320819(10)65492331
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K172767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/10/2024

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: 00436003600
• Device Lot Number: 65492331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female