MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US XTND GLENO D42MM +2MM; SHOULDER IMPLANT

Catalog Number 130762142

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2024

Event Type  malfunction  

Event Description

Intraoperative it was not possible to engage the glenosphere with the metaglene.A standard glenosphere was used.This was possible without issues.A surgical delay was not reported, no adverse patient consequences.

Manufacturer Narrative

Product complaint (b)(4) 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 : photographs were provided but they do not represent the current complaint condition or a device malfunction, example; photos of tags, photos of sticker sheets (and the allegation is unrelated to labeling), unrelated photos, etc.According to the information received, ¿intraoperative it was not possible to engage the glenosphere with the the metaglene.A standard glenosphere (b)(4) was used.This was possible without issues.A surgical delay was not reported, no adverse patient consequences.¿ the product was not returned to depuy synthes, however photos were provided for review.(b)(4).The photographs attached were reviewed, however they do not represent the reported complaint condition.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the photographs provided are not representative of the reported complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: XTND GLENO D42MM +2MM
• Type of Device: SHOULDER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19197113
• MDR Text Key: 341243498
• Report Number: 1818910-2024-09292
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295502500
• UDI-Public: 10603295502500
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192855
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130762142
• Device Lot Number: D23053934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1