MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL STEMS

Catalog Number UNK SHOULDER HUMERAL STEM

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

Patient Problems Bone Fracture(s) (1870); Hypersensitivity/Allergic reaction (1907)

Event Date 01/01/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed.Gutman mj, kohan em, hendy ba, joyce cd, kirsch jm, singh a, sherman m, austin ls, namdari s, williams gr jr.Factors associated with functional improvement after posteriorly augmented total shoulder arthroplasty.J shoulder elbow surg.2023 jun;32(6):1231-1241.Doi: 10.1016/j.Jse.2022.12.004.Epub 2023 jan 4.Pmid: 36610476.The purpose of this study was to identify preoperative and postoperative factors that impact range of motion (rom) and function after augmented tsa in patients with type b2 or b3 glenoid morphology.121 anatomic tsa implanted with apg glenoids and either global ap or global unite femoral stems.The cement mfg is unknown.Adverse event(s) possibly associated with unk shoulder glenoid global apg+ include adverse event(s) with quantity and intervention(s).2 patients with implant dislocations and treated with revisions.1 patient with glenoid loosening (unknown interface) treated with revision.Adverse event(s) possibly associated with unknown shoulder humeral heads include adverse event(s) with quantity and intervention(s).2 patients with implant dislocations and treated with revisions.1 patient with nickle allergy treated with revision.Adverse event(s) possibly associated with shoulder humeral stems include adverse event(s) with quantity and intervention(s).1 patient with humeral fracture treated with revision.1 patient with nickle allergy treated with revision.Adverse event(s) possibly associated with unk shoulder proximal body global include adverse event(s) with quantity and intervention(s).1 patient with nickle allergy treated with revision.

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.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.If additional information is made available, the investigation will be updated as applicable.Device history lot : the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNKNOWN SHOULDER HUMERAL STEMS
• Type of Device: SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19212744
• MDR Text Key: 341382571
• Report Number: 1818910-2024-09441
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

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 Catalogue Number: UNK SHOULDER HUMERAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention