MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 XTND GLENO D38MM +4MM; SHOULDER GLENOID

Model Number	1307-64-138
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	09/17/2020
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
It was reported patient had a previous mal union of a proximal humerus fracture and loss of anterior glenoid bone.Patient had dislocated post-op after having a reverse total shoulder.Doi: (b)(6) 2020, dor: (b)(6) 2020, right shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
Additional 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.
Event or Problem Description
Additional information received states that surgeon felt that he could not get the patients shoulder stable enough to not dislocate again.There was significant bone loss on the glenoid before the initial surgery.He felt it was best in the long run to remove the head and metaglene and put in a cta head hemi-arthroplasty.

• Brand Name: XTND GLENO D38MM +4MM
• Common Device Name: SHOULDER GLENOID
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10601105
• Report Number: 1818910-2020-21124
• Device Sequence Number: 3321705
• Product Code: KWS
• UDI-Device Identifier: 10603295502456
• UDI-Public: 10603295502456
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K183077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2020

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: 1307-64-138
• Device Catalogue Number: 130764138
• Device Lot Number: D19072595
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 09/30/2020; 11/04/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/05/2020; 11/05/2020
• 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 METAGLENE; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND STAND PE CUP D38 +6MM; XTND GLENO D38MM +4MM; DXTEND METAGLENE; DXTEND SCREW LOCK D4.5X24 MM; DXTEND SCREW NO LOCK D4.5X18 MM; DXTEND SCREW NO LOCK D4.5X18 MM; DXTEND STAND PE CUP D38 +6 MM; XTND GLENO D38 MM +4 MM
• Outcome Attributed to Adverse Event: Required Intervention