MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 40MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER; SHOULDER, PROSTHESIS

Catalog Number	00434906606
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a the patient is being considered for a shoulder revision due to unknown reasons.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02472, 0001822565-2023-02473, 0001822565-2023-02474, 0001822565-2023-02476 d10: 14mm ã¿ 130mm length humeral stem cat: 00434901413 lot: 65242785 40mm ã¿ glenosphere cat: 00434904011 lot: 65243512 12mm humeral stem spacer cat; 00434903912 lot: 65473774 +2mm lateral offset 25mm post length base plate cat: 00434902502 lot: 64759472 invers/revers scr syst 4.5-48 cat: 01.04223.048 lot: 2940206 invers/revers scr syst 4.5-42 cat: 01.04223.042 lot: 3082070.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.H3 other text : product not returned.
Event or Problem Description
It was reported a the patient is being considered for a shoulder revision due to dislocation.It was noted that the patients components are maxed out on length so the patient will be revised using competitor products.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: significant findings include single view of the right shoulder demonstrates a reverse total shoulder arthroplasty without radiolucency.No fracture.No dislocation.Reverse total shoulder arthroplasty without loosening, fracture or dislocation.A definitive root cause cannot be determined.The reported event is unable to be confirmed.If any further information is found that 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: 40MM ÿ +6MM OFFSET 65º NECK ANGLE RETENTIVE POLY LINER
• 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: 17724020
• Report Number: 0001822565-2023-02475
• Device Sequence Number: 15247994
• Product Code: HSD
• UDI-Device Identifier: 00889024269224
• UDI-Public: (01)00889024269224(17)281114(10)64759532
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 11/22/2023

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: 00434906606
• Device Lot Number: 64759532
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 11/20/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/03/2023; 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2020
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male