MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	00434906506
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and 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.0001825034-2023-00625, item#115313; lot#j7407973.0001822565-2023-00797, item# unkown stem; lot# unkown.Other associated products : item#00-4349-066-06; lot#63676333, item#110030777; lot#65560519, item#010000589; lot#881160, item#115313; lot#j7407973, item#118000; lot#j7329702.
Event or Problem Description
It was reported a patient underwent shoulder revision due to dislocation.During the procedure, it was noted the polyethylene had disassociated from the stem.The glenosphere and polyethylene were removed and replaced.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: stem identification found: 18mm 130mm length humeral stem cat#: 00434901813 lot#: 64008964.Visual evaluation of the returned product identified there is damage the spherical radius, rim feature, and backside features.Due to damage, dimensional analysis could not be performed.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.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: 36MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER
• 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: 16598893
• Report Number: 0001822565-2023-00796
• Device Sequence Number: 16569040
• Product Code: PHX
• UDI-Device Identifier: 00889024269194
• UDI-Public: (01)00889024269194(17)28018(10)65566647
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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: 00434906506
• Device Lot Number: 65566647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE NARRATIVE IN H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male