MAUDE Adverse Event Report: DEPUY IRELAND 9616671 XTNDGLENO D38MM +0MM SHRTPST; SHOULDER GLENOSPHERE

Model Number	1307-61-138
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
The patient was revised to address dislocation.Mechanism unknown.Doi: (b)(6) 2020, dor: (b)(6) 2021, left shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthese 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 : no lot information available.

• Brand Name: XTNDGLENO D38MM +0MM SHRTPST
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 11243827
• Report Number: 1818910-2021-01982
• Device Sequence Number: 19725582
• Product Code: PHX
• UDI-Device Identifier: 10603295502555
• UDI-Public: 10603295502555
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1307-61-138
• Device Catalogue Number: 130761138
• Device Lot Number: D20080945
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DXTEND STAND PE CUP D38 +9MM; XTNDGLENO D38MM +0MM SHRTPST; DXTEND STAND PE CUP D38 +9MM; XTNDGLENO D38MM +0MM SHRTPST
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 84