MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT SZ12 135 HIGH COL; CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

Catalog Number	L971112
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); Physical Asymmetry (4573); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was persistent complications following hip prosthesis surgeries.Patient underwent initial hip replacement in 2019, which consistently caused issues.From the moment of the operation, the patient complained of a measurement issue; his operated leg was 2 cm longer.After 4 years of pain and multiple visits to the surgeon, the patient decided to consult another surgeon.After several examinations, a revision was decided.In (b)(6) 2023, the loosened prosthesis was removed and a spacer was placed due to suspected infection.A new prosthesis was implanted in (b)(6) 2023, but pain and fluid buildup persist.Multiple tests (punctures, clean-up surgery, arthroscopy) have returned negative results.Referred to the hospital, where allergy is now being considered.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary persistent complications following hip prosthesis surgeries.Patient underwent initial hip replacement in 2019 in doornik, which consistently caused issues.In (b)(6) 2023, the loosened prosthesis was removed at [hospital] and a spacer was placed due to suspected infection.A new prosthesis was implanted in (b)(6) 2023, but pain and fluid buildup persist.Multiple tests (punctures, clean-up surgery, arthroscopy) have returned negative results.Referred to [hospital], where allergy is now being considered.Detailed composition of the prosthesis and cup is requested for further testing.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment info on products shared by patiënt.The photographs attached were reviewed, however they do not represent the reported complaint.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.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 manufacturing records evaluation (mre) was not performed.H11 additional narrative: added: d10 (concomitant) corrected: d3, g1 (manufacturing site name).

• Brand Name: CORAIL AMT SZ12 135 HIGH COL
• Common Device Name: CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22910981
• Report Number: 1818910-2025-14885
• Device Sequence Number: 9047768
• Product Code: MEH
• UDI-Device Identifier: 10603295455318
• UDI-Public: (01)10603295455318(17)280531(10)4215715
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K192946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: L971112
• Device Lot Number: 4215715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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 12/14 36MM +1.5; PINN MAR +4 10D 36IDX60OD; PINN SECTOR HA ACET CUP 60MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown