MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL AMT SZ11 STD COL; CORAIL IMPLANTS : HIP FEMORAL STEM

Catalog Number	L971211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post-operatively, the patient developed a urinary tract infection which has made them very ill.Infection in the joint has since developed, as surgeon noted patient had been doing well before the above infection.A revision of right tha due to infection following a dair was performed.Patient still had infection and required first stage revision to remove all components, wash out and debridement.Cemented a 52 liner and size 1 c stem placed for approximately 6 weeks, and will then fully revise.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as a valid lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: patient: right side, patient developed a urinary tract infection which has made them very ill.Infection in the joint has since developed as surgeon noted patient had been doing well before the above infection.Patient is considered medically overweight have requested bmi along with additional patient info, awaiting.Event: revision of tha due to infection following a dair (pc: ).Patient still had infection and required first stage revision to remove all components, wash out and debridement.Cemented a 52 liner and size 1 c stem in for approx.6 weeks and will then fully revise.Construct: pinnacle cup (b)(6), dual mobility liner (4313472), pe liner ((b)(6) + femoral head (b)(6), corail stem (b)(6)).The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.(b)(4).The photo investigation revealed foreign substance that appears to be organic material.However nothing indicative of a device nonconformance was found.The observed condition is consistent with the explanation process.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 observed condition of the corail amt sz11 std col would have not contributed to the complained adverse event.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.

• Brand Name: CORAIL AMT SZ11 STD COL
• Common Device Name: CORAIL IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21138860
• Report Number: 1818910-2025-00679
• Device Sequence Number: 12502055
• Product Code: MEH
• UDI-Device Identifier: 10603295478621
• UDI-Public: (01)10603295478621
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K213839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: L971211
• Device Lot Number: 3831184
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BI MENTUM ALTRX LNR 47 28.; DLT TS CER HD 12/14 28MM +5.0.; PINN SECTOR W/GRIPTION 54MM.; PINNACLE DM LINER 54_47.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female