MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 12MM ÿ 130MM LENGTH HUMERAL STEM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	00434901213
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Common device name: phx.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital will not release the product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Zimmer biomet will continue to monitor for trends.Associated products and reports; 0001822565-2023-00149 item#00436003600; lot#65356130, 0001822565-2023-00152 item#00434903603; lot#65352850.Other associated products: item#00436202000; lot#64390359n, item#47436108300; lot#56672638, item#0104223033; lot#3021582, item#0104223042; lot#3127010, item#47430906125; lot#65267726, item#47430904601; lot#65157507 and item#47430902501; lot#65553821.
Event or Problem Description
It was reported patient underwent a right shoulder revision approximately two (2) weeks post implantation due poor bone quality, dislocation, and fixation of implant.Attempts have been made and no further information has been provided.
Event or Problem Description
Upon reassessment of the reported event, it was determined loosening mentioned in the complaint description was referencing the baseplate, not the stem.The baseplate will be reported under 0001822565-2023-01188.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay correction, additional information and device evaluation.Proposed annex g code: mechanical (g04) - stem.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: relative radiolucency of the glenoid suggests severe osteopenia.However, no definite fracture can be seen.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.Upon reassessment of the reported event, it was determined loosening mentioned in the complaint description was referencing the baseplate, not the stem.The baseplate will be reported under 0001822565-2023-01188.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 12MM ÿ 130MM LENGTH HUMERAL STEM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 16196873
• Report Number: 0001822565-2023-00148
• Device Sequence Number: 6053518
• Product Code: PHX
• UDI-Device Identifier: 00889024268951
• UDI-Public: (01)00889024268951(17)321009(10)65538166
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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 Catalogue Number: 00434901213
• Device Lot Number: 65538166
• 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: 12/23/2022
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 81 KG