MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND MOD EPI 1 ECC RIGHT HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number	130720103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that this was a rtsa performed in 2020.The surgery was completed successfully with no surgical delay.After surgery, on (b)(6) 2022, the sales rep was informed by the surgeon that the patient had a delayed infection.The sales rep suggested to the surgeon that the treatment should be performed by debridement if the infection was mild or by removing the implant, doing debridement, and filling cement beads containing antibiotics if the infection was severe, etc.However, when the situation was checked again, the following situations were found.; some disease developed in the axilla after surgery, and the patient visited the dermatology department.Since the condition did not improve, the surgeon began to suspect that the infection was caused by the implants used in the initial surgery.Ulcer and granulation have formed in the axilla, and mrsa has been attached from the skin.The surgeon commented that the cause of infection was propionibacterium acnes.Slight osteolysis is observed on the stem site medially, but there is no instability both on the base plate site and stem site so far.Because the infection was expected to be quite severe, the sales rep suggested to the surgeon that prudent procedures be taken.
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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DXTEND MOD EPI 1 ECC RIGHT HA
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15916301
• Report Number: 1818910-2022-24324
• Device Sequence Number: 12461937
• Product Code: KWS
• UDI-Device Identifier: 10603295027300
• UDI-Public: 10603295027300
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192855
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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: 130720103
• Device Catalogue Number: 130720103
• Device Lot Number: 5345769
• 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: 11/14/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2019
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DXTEND GLENOSPHERE STD D38MM; DXTEND METAGLENE; DXTEND MOD EPI 1 ECC RIGHT HA; DXTEND MODULAR HUM STEM D12 HA; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X42MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND STAND PE CUP D38 +3MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown