MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 EMSYS SHL 3HOLE 54; HIP IMPLANT : ACETABULAR CUP

Catalog Number 471054300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Osteolysis (2377); Unspecified Musculoskeletal problem (4535)

Event Date 01/03/2024

Event Type  Injury  

Event Description

Subject id: (b)(6); study no: dots.Clinical notification received for revision due to periprosthetic fracture.Date of implant: (b)(6) 2023; date of revision: (b)(6) 2024; (left hip).Treatment: stem and head were revised.Medical records review (22_jan_2024_08_09_04_18105): on (b)(6) 2024, patients left total hip was revised to address chronic infection with progression of periprosthetic osteolysis of both femoral and acetabular bone.During the revision surgical procedure, it was identified that the femoral stem was loose, that it had only a fibrous ingrowth.There was an osteolytic defect beneath the superior aspect of the acetabular cup, but the cup was well-fixed.There was osteolysis of the femoral canal.The stem, femoral head, cup, liner and two acetabular screws were all explanted.A temporary antibiotic spacer, made up of an antibiotic cemented depuy summit stem, was cemented in place along with stimulant pellets, and paired with a bipolar head.Two synthes cerclage cables were placed on the proximal femur to address a calcar fracture that occurred intraoperatively during broaching for the spacer summit stem.The patient tolerated the procedure well, with no other complications apart from the calcar bone fracture caused by the summit broach.

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.

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 manufacturing records evaluation (mre) was not performed.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.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: EMSYS SHL 3HOLE 54
• Type of Device: 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 ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18641169
• MDR Text Key: 334557597
• Report Number: 1818910-2024-02328
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 471054300
• Device Lot Number: 4290151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ARTICULEZE HD CER 40OD +5; EMSYS LNR AOX +4N 54X40; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX35MM; SUMMIT POR TAPER SZ5 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White