MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US XTND GLENO ECC D38MM +2MM; SHOULDER GLENOSPHERE

Model Number 1307-62-038

Device Problems Difficult to Insert (1316); Device Damaged Prior to Use (2284)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

Surgeon was implanting glenosphere component as part of a reverse shoulder arthroplasty and had difficulty getting implant to seat.Screwdriver kept turning and never tightened despite changing exposure and positioning.Eventually surgeon pulled out the implant and found that the threads had been damaged.He ended up implanting a new, similar, implant and this time was able to engage the threads.Surgery was then completed in the usual fashion.

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).Investigation summary : examination of the returned device found could confirm the reported allegation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : device history record (dhr) review was conducted by the manufacturing site for the finished device 130762038, lot number d19101605, it was manufactured on 22-oct-2019.(b)(4) pcs parts were manufactured per specification and all raw materials met specification, and no non-conformances were identified.

Event Description

Affected side: right shoulder.

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.

• Brand Name: XTND GLENO ECC D38MM +2MM
• Type of Device: SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12829059
• MDR Text Key: 285768432
• Report Number: 1818910-2021-25410
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295502432
• UDI-Public: 10603295502432
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K183077
• 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: 11/01/2021

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 Model Number: 1307-62-038
• Device Catalogue Number: 130762038
• Device Lot Number: D19101605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 12/16/2021; 01/24/2022
• Supplement Dates FDA Received: 01/05/2022; 01/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2019
• 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