MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CROSSLINK ANCHOR PG GLENOID 52; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID

Model Number	1136-43-026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Heart Failure/Congestive Heart Failure (4446)
Date of Event	10/18/2021
Type of Reportable Event	Death
Event or Problem Description
(b)(6).The case is still ongoing, our assessment therefore preliminary: seriousness: yes, causality to medical device: no, causality to study procedure: yes (possible), expectedness: yes, influence on risk/benefit ratio: no, proposed measures for patient safety: none.Our narrative at the moment: a (b)(6) male participant of the (b)(6) study who had undergone surgical implantation of global icon shoulder prosthesis on (b)(6) 2021 as per study protocol experienced a bilateral fulminant pulmonary embolism that led to a cardiovascular standstill on (b)(6) 2021 4:20 p.M.The investigator assessed the event as not related to the medical device but possibly to the study procedure (surgical implantation).The patient has currently regained his own rhythm but is still on extracorporeal membrane oxygenation (ecmo).The event is still ongoing.Site awareness date: 18-10-2021.Date of surgery : (b)(6) 2021.
Additional Manufacturer Narrative
Product complaint # (b)(4).The patient's pulmonary function continued to deteriorate, and the patient died on (b)(6) 2021.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Medical records () reviewed: the clinical study identified the following, which is comparable to information already provided by the clinical site adverse event reporting system: the second subject (b)(6) received the global icon implant on (b)(6) 2021, but died on (b)(6) 2021 (sae no.(b)(4), bfarm- reference# (b)(4).As of the clinical study "reporting date, 42 patients in the study received one of the two test products (21 the global icontm shoulder prosthesis and 21 the simplicititm comparative product).Among them, a complication "pulmonary embolism" with fatal outcome occurred - the case (sae no.(b)(4)) was immediately reported to the competent federal authority in october 2021 (bfarm reference# (b)(4)).To date, the sponsor has been notified of a death: patient (patient id: (b)(6) ) died 10 days after implantation surgery as a result of pulmonary embolism complications (see narrative in the sae table).The mortality rate in the rsa global icon study is currently 1/42 = 2.4% for 42 patients who have received one of the two study products.The review of the study results in these medical records provides no new information with respect to the reported death, secondary to bilateral pulmonary embolism and cardiac arrest.No impacted product or coding updates is required.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added : b5.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.

• Brand Name: CROSSLINK ANCHOR PG GLENOID 52
• Common Device Name: GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 -098
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581--098 ; 6107428552
• MDR Report Key: 12811579
• Report Number: 1818910-2021-25094
• Device Sequence Number: 17775278
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/15/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 1136-43-026
• Device Catalogue Number: 113643026
• Device Lot Number: J3217N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 11/19/2021; 04/22/2024; 07/15/2024; 08/05/2025; 07/17/2026
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 11/21/2021; 04/29/2024; 07/17/2024; 08/25/2025; 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2019
• 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: ANCHOR PLATE SIZE 54; CROSSLINK ANCHOR PG GLENOID 52; HUMERAL HEAD SIZE 54
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 60 YR
• Patient Sex: Male