MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLB SHD END PEG GLEN 48 GBB; GLENOID (KEELED AND 5-PEGGED) IMPLANT : SHOULDER GLENOID

Catalog Number 113786045

Device Problems Loss of or Failure to Bond (1068); Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2022

Event Type  Injury  

Event Description

In 2011 the patient underwent a tsa for treating osteoarthritis in the shoulder joint glenoid.On an unknown date the patient underwent a revision procedure due to the loose shoulder blade component.The surgeon commented the following: 1.After the shoulder blade component in question was explanted, any replacing device was not implanted in the glenoid.Instead, ilium bone implantation was applied.The polyethylene area on the explanted shoulder blade component had worn out.2.A 112852110 head (lot # d97hy1) was replaced with a 112852120 head.

Manufacturer Narrative

Product complaint # (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).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.

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: GLB SHD END PEG GLEN 48 GBB
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13335147
• MDR Text Key: 285543473
• Report Number: 1818910-2022-01499
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 01/24/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113786045
• Device Lot Number: CE3FR1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2022
• Initial Date FDA Received: 01/24/2022
• Supplement Dates Manufacturer Received: 01/26/2022; 02/25/2022
• Supplement Dates FDA Received: 01/31/2022; 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2008
• 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 ECC HD 52X18 (112852110/D97HY1)
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male