MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 SHORT STEM XS 28; SHOULDER IMPLANT - HUMERAL STEM

Model Number 5200-01-028

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/07/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clinical adverse event received for lateral humeral cortex stem perforation and humeral bone fracture.Event is considered mild.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2022.Date of revision: (b)(6) 2022.Date of event: (b)(6) 2022.(left shoulder) treatment: revision; stem and head were revised.

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.

• Brand Name: SHORT STEM XS 28
• Type of Device: SHOULDER IMPLANT - HUMERAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15897520
• MDR Text Key: 304680138
• Report Number: 1818910-2022-24146
• Device Sequence Number: 1
• Product Code: MBF
• UDI-Device Identifier: 10603295538233
• UDI-Public: 10603295538233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

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
• Device Operator: Health Professional
• Device Model Number: 5200-01-028
• Device Catalogue Number: 520001028
• Device Lot Number: 172901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANATOMIC GLENOID XS 21.5; GLBL UNITE ANT BODY 128 SZ 10; GLOBAL UNITE BODY SZ 10 -5; GLOBAL UNITE HEAD 44X15 ECC; HUMERAL HEAD 44X17.25
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White