MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL AMT SZ12 STD COL; CORAIL IMPLANTS : HIP FEMORAL STEM

Catalog Number	L971212
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon had planned to use a corail in the operation.The broach size 12 was very well placed, but when we inserted the implant it would not seat.He took the stem out and used the rasps again, but the implant could not be seated.He decided to change to corail cemented instead.
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).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 health effect - clinical code & health effect - impact code.
Event or Problem Description
Additional information received: a.Was there any surgical delay related to the event? if yes, what is the duration of the delay? -yes 30 min.B.Was there any patient consequence related to the event? -there was no consequence for the patient.
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.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: description of complaint (please supply specific details): the surgeon had planned to use a corail [product code removed] in the operation, the broach size 12 was very well placed, but when we inserted the implant it was not seated.He took the stem out and used the rasps again, but the implant could not be seated.He decided to change to corail cemented instead.He wants j&j to investigate if the stem has the right dimensions, as he is a skilled surgeon and can't see what he could have done wrong.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found nothing indicative of a device nonconformance.A dimensional inspection was performed and met specifications.A functional evaluation was not performed as it is not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the corail amt sz12 std col would not contribute to the complained device issue.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 reported complaint condition.As part of depuy synthes 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.Drawing: 103177875, rev a.Feature: width of the neck.Specification: 9.73 +/- 0.20 mm.Measured dimension: 9.89 mm.Device used: mitutoyo digimatic caliper id#: cd78627.Feature: middle length of the implant.Specification: 45.00 +/- 1.00 mm.Measured dimension: 45.70 mm.Device used: mitutoyo digimatic caliper id#: cd78627.Feature: circumference of the neck.Specification: 13.11.+/- 0.20 mm.Measured dimension: 13.08 mm.Device used: mitutoyo digimatic caliper id#: cd78627.Device history lot: a manufacturing record evaluation was performed for the finished device product code: l971212, lot number: 4327100, and no non-conformance's / manufacturing irregularities were identified during manufacturing.Device history review: a manufacturing record evaluation was performed for the finished device product code: l971212, lot number: 4327100, and no non-conformance's / manufacturing irregularities were identified during manufacturing.Corrected: d4 primary udi number.

• Brand Name: CORAIL AMT SZ12 STD COL
• Common Device Name: CORAIL IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; 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: 18987107
• Report Number: 1818910-2024-06824
• Device Sequence Number: 16861037
• Product Code: MEH
• UDI-Device Identifier: 10603295478638
• UDI-Public: (01)10603295478638(17)281231(10)4327100
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K213839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: L971212
• Device Lot Number: 4327100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/09/2024; 04/24/2024; 07/22/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/11/2024; 04/26/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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
• Patient Sex: Unknown