MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS SHL 3HOLE 48; HIP IMPLANT : ACETABULAR CUP

Catalog Number	471048300
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Hematoma (1884); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(6).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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
Clinical notification received for revision due to malposition/non union trochanter.Date of implant: (b)(6) 2023.Date of revision: (b)(6) 2023.(right hip).Treatment: head, liner, stem, and cup were revised.
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.H10 additional narrative: 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
Additional information was received: clinical notification received for revision due to malposition/non-union trochanter.Date of implant: (b)(6) 2023.Date of revision: (b)(6) 2023.(right hip).
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.H10 additional narrative:.
Event or Problem Description
Operative notes reviewed.On (b)(6) 2023, the patient had a revision right total hip arthroplasty to address failed right total hip arthroplasty secondary to the protrusion of the acetabular cup into the pelvis with posterior column and ischial fracture.The patient also had an open reduction and internal fixation, posterior column fracture using 3.5mm pelvic reconstruction plates, and bone graft.The patient also reported having pain.The surgeon observed a posterior column fracture, a large defect in the posterior superior wall and column.The femoral stem was revised in order to provide better exposure during the acetabular reconstruction.The surgeon observed a large area of healing hematoma in the gluteus and also ecchymosis over her anterior knee which the surgeon correlated with a fall.Depuy components, including depuy protrusion cage and cement, were used during this procedure.

• Brand Name: EMSYS SHL 3HOLE 48
• Common Device Name: HIP IMPLANT : ACETABULAR CUP
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17450944
• Report Number: 1818910-2023-15906
• Device Sequence Number: 7383472
• Product Code: LPH
• UDI-Device Identifier: 10603295500582
• UDI-Public: 10603295500582
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K221636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 471048300
• Device Lot Number: 3963165
• 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: 07/21/2023
• Supplement Date Received by Manufacturer: 08/16/2023; 08/22/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/16/2023; 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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: ARTICULEZE M HEAD 36MM +5; EMSYS LNR AOX +4N 48X36; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; SUMMIT POR TAPER SZ5 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 91 KG