MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 14MM ÿ 130MM LENGTH HUMERAL STEM; SHOULDER, PROSTHESIS

Model Number	00-4349-014-13
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01761, 0001822565-2023-01762 d10: 36mm vit e liner +0mm cat: 00435003600 lot: 65532361 36mm vit e liner +0mm cat: 00435003600 lot: 65585396 customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
Event or Problem Description
It was reported that the tm reverse poly did not impact onto stem.Subsequently, a humeral fracture occurred due to this issue.The poly was impacted onto the stem on the back table then re-implanted.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
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.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.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The reported event is not confirmed.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: 14MM ÿ 130MM LENGTH HUMERAL STEM
• 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: 17248663
• Report Number: 0001822565-2023-01764
• Device Sequence Number: 12077195
• Product Code: HSD
• UDI-Device Identifier: 00889024268975
• UDI-Public: (01)00889024268975(17)330416(10)65840581
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 12/12/2023

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 Model Number: 00-4349-014-13
• Device Catalogue Number: 00434901413
• Device Lot Number: 65840581
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• 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: Other
• Patient Sex: Female