MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 XTEND MODECC 145EPI POR SZ1 RT; JRN : SHOULDER HUMERAL STEM ACCESSORY

Model Number	1307-20-113
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Right side: revision of a delta xtend due to infection.The patient had a previous revision surgery a few years ago.Unable to confirm exact date.Reason for this was due to glenoid notching and pain.At this revision the 155 epi was removed, glenoid was removed.Unsure if the metaglene and screws were too.The stem was retained, and it was converted to a 145 epi with lateralised glenosphere.Patient notes were unavailable to confirm exact dates and lot numbers.I'm unable to confirm what pc this was logged against too.Today we removed all implants as per impacted products.4x screws were also removed, but i'm unable to confirm the ref and lot numbers for these.A spacer was implanted until the infection clears.Was surgery delayed due to the reported event? unknown, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? --> unknown, patient status/ outcome / consequences , was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study :unknown, (b)(4).Device property of :none, device in possession of :none, (b)(4).Device property of :none, device in possession of :none, (b)(4).Device property of :none, device in possession of :none, (b)(4).Device property of :none, device in possession of :none, (b)(4).Device property of :none, device in possession of :none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst:true.
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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary; the device associated with this report was not returned to depuy synthes for evaluation.Visual inspection of the provided photographic evidence revealed there was no significant product problem observed on the surface of the device.There is no evidence that suggests the reported adverse event was due to a device non conformance.Based on the provided evidence, the investigation was not able to confirm the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 records evaluation (mre) was not performed.

• Brand Name: XTEND MODECC 145EPI POR SZ1 RT
• Common Device Name: JRN : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17050840
• Report Number: 1818910-2023-11446
• Device Sequence Number: 7039650
• Product Code: PHX
• UDI-Device Identifier: 10603295510246
• UDI-Public: 10603295510246
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 06/02/2023

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 Model Number: 1307-20-113
• Device Catalogue Number: 130720113
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 07/20/2023
• 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 METAGLENE.; DXTEND MODULAR HUM STEM D12 HA.; DXTEND STAND PE CUP D42 +6MM.; UNKNOWN SHOULDER LOCKING SCREW.; UNKNOWN SHOULDER LOCKING SCREW.; UNKNOWN SHOULDER NON-LOCKING SCREW.; UNKNOWN SHOULDER NON-LOCKING SCREW.; XTND GLENO D42MM +4MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female