MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	523418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Pain (1994); Respiratory Failure (2484); Ambulation or Postural Difficulties (2544); Thrombosis/Thrombus (4440); Renal Impairment (4499); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Clinical adverse event received for vascular - pe device related: definitely not procedure related: probably date of event: august 20, 2024 date of implant: no information provided.Date of revision: no information provided.Device location: no information provided.Treatment/impact: no information provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: h6: e2402 (appropriate term/code not available) is being utilized to capture (hypothyroidism) generalized disorders (e23).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Operative note ad 14 oct 2024 was reviewed by a clinician.On (b)(6) 2024, the patient underwent a left tha due to increasing pain and difficulty walking.Post-operatively the patient sustained an acute pe in the right lower lobe.She was treated with a heparin drip.She also had a non-occlusive dvt in the left leg.This was likely the original clot from the pe.She went into obstructive shock from the pe requiring norepinephrine in the icu.She was also diagnosed with encephalopathy, acute hypercapnic and hypoxemic respiratory failure, hyponatremia, and an acute kidney injury.Pmh includes chf, hypothyroidism, morbid obesity, adhd, and obstructive sleep apnea.Patient was discharged home on (b)(6) 2024 with home health services.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.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 perform.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.H11 additional narrative: added: b7.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20326536
• Report Number: 1818910-2024-20366
• Device Sequence Number: 7903056
• Product Code: MRA
• UDI-Device Identifier: 10603295171034
• UDI-Public: (01)10603295171034(17)280430(10)4144001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/18/2024

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: 523418
• Device Lot Number: 4144001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 10/14/2024; 11/04/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/15/2024; 10/18/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2023
• 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: DELTA CER HEAD 11/13 36MM +0.; PINN CAN BONE SCREW 6.5MMX15MM.; S-ROM*SLEEVE PRX ZTT, 18D-SML.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Unknown
• Patient Weight: 134 KG