MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE STD STEM SZ 10; GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS

Catalog Number	110010100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/09/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient was being converted from a global unite to delta construct due to fracture stem.No further patient information available.Doi: (b)(6) 2019.Dor: (b)(6) 2019; left shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: GLOBAL UNITE STD STEM SZ 10
• Common Device Name: GLOBAL UNITE IMPLANTS : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9538755
• Report Number: 1818910-2020-00101
• Device Sequence Number: 2300032
• Product Code: KWS
• UDI-Device Identifier: 10603295004080
• UDI-Public: 10603295004080
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 110010100
• Device Lot Number: 9090501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/17/2020
• 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: GLOBAL UNITE BODY SZ 10 +5; GLOBAL UNITE COLLAR SZ 44; GLOBAL UNITE HEAD 44X21 STD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR