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

Catalog Number	130720102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	07/24/2023
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 the patient had a right delta xtend reverse shoulder replacement approximately 6 months ago.Patient represented to surgeon complaining of pain, unexplained origin.Procedure; first stage revision of all components and insertion of global ap hemiarthroplasty cement 'spacer'.Upon opening the shoulder and examining the joint the surgeon suspected a low grade infection was present.Multiple specimens and swabs were taken.Doi: unknown, doe: (b)(6) 2023, affected side: right shoulder.
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 - a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: DXTEND MOD EPI 1 ECC LEFT 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17480060
• Report Number: 1818910-2023-16237
• Device Sequence Number: 16822311
• Product Code: KWS
• UDI-Device Identifier: 10603295027294
• UDI-Public: 10603295027294
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 08/08/2023

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: 130720102
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 08/28/2023
• 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 ECC D38MM; DXTEND METAGLENE; DXTEND MODULAR HUM STEM D10 HA; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW; UNKNOWN SHOULDER NON-LOCKING SCREW; X-LINK HIMO HUM CUP 38+3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female