MAUDE Adverse Event Report: JOINT RECON CE LM : DEPUY IRELAND CORAIL AMT SZ10 125 STD COL; CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

Model Number	L971210
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
On (b)(6) 2021 first intention pth, on (b)(6) 2021 revision pth, implantation of the femoral stem performed on (b)(6) which required a surgical revision with a change of stem and head on (b)(6) with a cemented stem.On (b)(6) there was a problem when removing the impactor, which remained attached to the stem.This reduced the strength of the final stem and caused it to sink in.Then it was necessary to explant it during a second surgery.Doi: (b)(6) 2021.Dor: (b)(6) 2021; affected side: unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary examination of the returned stem finds nothing outward to suggest product error.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.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 a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
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: added: b5, h6 health effect - impact code.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 received states that the revision was due to depressions and there was a 5 minutes delay.

• Brand Name: CORAIL AMT SZ10 125 STD COL
• Common Device Name: CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): JOINT RECON CE LM : DEPUY IRELAND; loughbeg ringaskiddy; cork P43 E D82; EI P43 ED82
• MDR Report Key: 11664078
• Report Number: 1818910-2021-07862
• Device Sequence Number: 3015129
• Product Code: LPH
• UDI-Device Identifier: 10603295455400
• UDI-Public: 10603295455400
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2021

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 Model Number: L971210
• Device Catalogue Number: L971210
• Device Lot Number: 9606417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/14/2021; 06/07/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 04/27/2021; 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 22.225+4 NK.; ARTICUL/EZE BALL 22.225+4 NK
• Outcome Attributed to Adverse Event: Required Intervention