MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL AP HUMERAL HD 44X15 ECC; GLOBAL AP IMPLANTS : SHOULDER HUMERAL HEADS

Model Number	1130-44-600
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	09/30/2020
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
Patient received total left shoulder index surgery.Dr.Had to close reduce the patient's left shoulder due to a posterior dislocation of the humeral head on (b)(6) 2019.Dr elected to revise the patients left shoulder from an anatomic to a reverse shoulder on (b)(6) 2020.Dr.Removed the index components.All were well fixed.There were no loose components.There was no mention by anyone that the components contributed to the need to revise the shoulder.No pieces or instruments broke during the case and there was no extension in time as a result of depuy products.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.

• Brand Name: GLOBAL AP HUMERAL HD 44X15 ECC
• Common Device Name: GLOBAL AP IMPLANTS : SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10680434
• Report Number: 1818910-2020-22302
• Device Sequence Number: 2942617
• Product Code: HSD
• UDI-Device Identifier: 10603295005872
• UDI-Public: 10603295005872
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted 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): 09/29/2020

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: 1130-44-600
• Device Catalogue Number: 113044600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/24/2020
• 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 AP 135 DEG TAPER ASSEM.; GLOBAL AP HUMERAL HD 44X15 ECC.; GLOBAL AP HUMERAL STEM 12MM.; STEPTECH APG 44+5MM LEFT.; GLOBAL AP 135 DEG TAPER ASSEM; GLOBAL AP HUMERAL HD 44X15 ECC; STEPTECH APG 44+5MM LEFT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR