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

Model Number 1307-62-042

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 10/27/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision completed due to dislocation.There was no surgical delay.Doi: unknown; dor: (b)(6) 2022; affected side: right shoulder.

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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: XTND GLENO ECC D42MM +2MM
• Type of Device: SHOULDER IMPLANT : GLENOSPHERE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15793903
• MDR Text Key: 303622383
• Report Number: 1818910-2022-22877
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295502449
• UDI-Public: 10603295502449
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

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 Model Number: 1307-62-042
• Device Catalogue Number: 130762042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 11/23/2022
• 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: DXTEND RETENT PE CUP D42 +6MM
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male