MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ADEPT® EXTRA FIXATION METAL ON METAL CUP 46MM 38MM BORE; ADEPT IMPLANT : HIP METAL ACETABULAR CUPS

Catalog Number 174461

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Itching Sensation (1943); Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Legal notification: due to dysplastic right coxarthrosis the patient underwent total hip arthroprosthesis surgery on (b)(6) 2020 where he received an adept 46 cupef implant with 2 screws 44mm, 16mm, adept stem size 15 with mn (ox) and head 38+3.5mm.Since 2013, the patient has experienced itching, swelling, pain and feeling of warmth in the lower limbs.On (b)(6) 2018, the patient performed blood tests where plasma chromium 6ug/l and blood cobaldo 9.22ug/l.Were found.On (b)(6) 2018, the patient performed a bone scan, the conclusions of which indicate: a polyphasic bone scan study compatible with the mobilization of the arthroprotsi of the right hip.This framework of prosthetic mobilization led the patient to address on (b)(6) 2018 for a consultation at the doctor's office of dr.(b)(6), which certises the following: "diagnosis: right coxalgia in the outcome of a right total hip prosthesis operation with periprosthetic scintigraphic hypercapture of the right femoral shaft exhibits.The required bone scan, lumbar spine ct and blood tests (no nickel, chromium, cobalt dosage), the rx show femoral stem undersized and varus compared to the femoral diaphyseal canal review of the right femoral stem is envisaged the patient is pisserous tomer with previous blood and rx tests and new rx of the pelvis and right femur should he decide for revision operation of total hip prosthesis at need for continuous pain with dichloreum cps 15 mg + gastropothection".On (b)(6) 2019, he was admitted to the u.O.Orthopedics of the instituto clinico (b)(4) with diagnosis of: "posturni pta right" where she remained in hospital until (b)(6) 2019 date when she was discharged with diagnosis of "aseptic mobilization of the right hip femoral stem".She underwent a surgical procedure of "revision and replacement of the right hip stem" on (b)(6) 2019.On (b)(6) 2021 he performed a bone or segmented joint scan polyphasica showing: "polyphasic study: regular vascular phase with no signs of hyperhernia, in the blood pool phase, late phase and present indicator accumulation against the prosthetic right femoral stem.Total body study: no significant findings.Conclusion: initial signs of rearrangement of the prosthetic stem of the right hip endoprosthesis without scintigraphic signs of phlogistic/septic overlap".For this reason he carried out on (b)(6) 2021 an outpatient visit at the (b)(4) clinical institute in (b)(6), where the doctor recommended performing a ct scan of the pelvis, magnetotherapy, ultrasound of the adductive muscles of the right femur and anti-osteoporotic therapy.The following year (b)(6) 2021 carried out a new outpatient visit to the doctor's office of dr.(b)(6), who objected to the following: "it comes to check.Operated in 2010 on the right hip due to congenital dysplasia.Metal/metal system.Due to increased metal ions and pain it was reviewed two years ago ((b)(6) 2019).Currently there is dm shell with a cemented short stem that has cement debonding.The pattern of mobilization of the implant is confirmed by bone scan.Revising femoral stem surgery is scheduled.On (b)(6) 2021, the patient, performed pre-operative exarni, anesthesiological examination and signed regular consents, was started to a new surgical procedure of: "revision of hip prosthesis, both acetabular and femoral components, reimplantation arthroprosthesis right hip" for aseptic mobilization arthroprosthesis right hip hybrid.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.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.However, if the product is received at a later date, the investigation will be updated as applicable.

Manufacturer Narrative

Product complaint # : (b)(4).D4.Unique identifier( udi) : udi/gtin information is not applicable.Product was placed into distribution prior to the udi requirement.It was recalled in january 2014 and was never marketed in the usa.

• Brand Name: ADEPT® EXTRA FIXATION METAL ON METAL CUP 46MM 38MM BORE
• Type of Device: ADEPT IMPLANT : HIP METAL ACETABULAR CUPS
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15064491
• MDR Text Key: 296215912
• Report Number: 1818910-2022-13461
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/20/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 174461
• Device Lot Number: 91012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/20/2022
• Supplement Dates Manufacturer Received: 07/20/2022; 08/03/2022; 08/03/2022
• Supplement Dates FDA Received: 07/28/2022; 08/03/2022; 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ADEPT STEM SIZE 15 WITH MN (OX); ADEPT® 12/14 METAL ON METAL MODULAR HEAD; ADEPT® EXTRA FIXATION METAL ON METAL CUP; ADLER ALATA ACUTA STANDARD HIP STEM; ADLER MODULA NECK; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female