MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 DXTEND MOD CENT EPI 1 HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number	130720101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional 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.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
On an unknown date, the primary rsa was performed with delta xtend system.On an unknown date, it was found that the patient had postoperatively become infected.On an unknown date, they removed the devices in question, cleansed the lesion and completed device replacements.

• Brand Name: DXTEND MOD CENT EPI 1 HA
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12908245
• Report Number: 1818910-2021-26642
• Device Sequence Number: 4828571
• Product Code: HSD
• UDI-Device Identifier: 10603295027287
• UDI-Public: 10603295027287
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 130720101
• Device Catalogue Number: 130720101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DXTEND GLENOSPHERE STD D38MM; DXTEND MOD CENT EPI 1 HA; DXTEND STAND PE CUP D38 +3MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male