MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 SHORT PC HUMERAL STEM 16X61

Model Number 1100-16-800

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

Patient Problem Bone Fracture(s) (1870)

Event Date 02/23/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent right reverse tsa.Implanting the 16 short stem & epi 145 right, there was a crack in the humerus.The humerus was cerclage and a decision was made to implant a standard length stem.It is acknowledged by the surgeon that there are not short stem trials available.There was a 40 minutes surgical delay.Doi: (b)(6) 2022.Dor: (b)(6) 2022.Affected side: right shoulder affected.

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

• Brand Name: SHORT PC HUMERAL STEM 16X61
• Type of Device: 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13720080
• MDR Text Key: 286921746
• Report Number: 1818910-2022-04389
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295523383
• UDI-Public: 10603295523383
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1100-16-800
• Device Catalogue Number: 110016800
• Device Lot Number: D21111959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• 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: SHORT PC HUMERAL STEM 16X61.; XTEND MODECC 145EPI POR SZ1 RT.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male