MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CORAIL2 STD SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92512

Device Problems Inaccurate Information (4051); Wrong Label (4073)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2022

Event Type  malfunction  

Event Description

Customer is complaining the color-coding at the outer package of corail stems.As per surgery technique the green marking at the outer package indicates a 135° offset.Now the customer received a stem with 135° offset that shows a blue marking.As per surgery technique the blue marking should indicate a 125° offset.

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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was not returned to depuy synthes for evaluation.The photo investigation revealed enough evidence to confirm the reported allegation.The colored marking is incorrect.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a search of the depuy nonconformance (nc) quality system found 1 unrelated past nc¿s associated with this product/lot combination.However an nc was raised to address the current complaint issue.1) quantity manufactured: 12 parts 2) date of manufacture: 26 september 2022 3) any anomalies or deviations identified in dhr: 1 non-conformance associated with this lot, however there is no correlation between this non-conformance and the failure mode of the complaint.4) expiry date: 31 august 2027 5) ifu reference: w90918 ifu corail 2 hip stem device history review
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> 1) quantity manufactured: 12 parts 2) date of manufacture: 26 september 2022 3) any anomalies or deviations identified in dhr: 1 non-conformance associated with this lot, however there is no correlation between this non-conformance and the failure mode of the complaint.4) expiry date: 31 august 2027 5) ifu reference: w90918 ifu corail 2 hip stem.

• Brand Name: CORAIL2 STD SIZE 12
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15851205
• MDR Text Key: 304363134
• Report Number: 1818910-2022-23582
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295168782
• UDI-Public: 10603295168782
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192946
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2022

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
• Device Operator: Health Professional
• Device Model Number: 3L92512
• Device Catalogue Number: 3L92512
• Device Lot Number: 3927638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 12/19/2022; 12/27/2022
• Supplement Dates FDA Received: 12/21/2022; 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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: CORAIL2 STD SIZE 12; CORAIL2 STD SIZE 12