MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL SHD END PEG GLEN 40; GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID

Model Number 1137-84-025

Device Problem Naturally Worn (2988)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/06/2023

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

Revision of left shoulder anatomic replacement - removal of all components suspected poly wear/debris causing significant glenoid wear - custom reverse zimmer components going back in global advantage original implant (b)(6) 2008.(b)(6) hospital following up with cs on lot numbers of implants no further info available.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown, did the patient require revision surgery or hardware removal? --> yes, facility name of original implant : (b)(6) war memorial , was device explanted? true, hardware/explant removal due to: as above , did patient require revision surgery? false, patient status/ outcome / consequences , was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study : unknown, ip-01749407.Device property of :none, device in possession of :none, ip-01749408.Device property of :none, device in possession of :none, ip-01749409.Device property of :none, device in possession of :none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst:true.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this complaint was not received for examination.Available photograph was reviewed, and it was found out that the posts are worn.No other defect was found.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: GLOBAL SHD END PEG GLEN 40
• Type of Device: GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17162903
• MDR Text Key: 317472728
• Report Number: 1818910-2023-12525
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10603295007227
• UDI-Public: 10603295007227
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K914000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1137-84-025
• Device Catalogue Number: 113784025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2023
• 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
• Treatment: GLOBAL ADVANTAGE HUM HD 40X18.; GLOBAL ADVANTAGE STEM 8 MM.
• Patient Outcome(s): Required Intervention