MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CORAIL2 STD SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92512

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 05/31/2023

Event Type  malfunction  

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.

Event Description

It was reported that a hair was trapped in the implant packaging.A different stem was then opened and implanted into the patient.

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.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the device and review of the photographic evidence confirm the reported allegation.A hair like material was observed inside the outer casing of the implant packaging.In addition, the tyvek seal was found open.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device [3l92512 / 3976712] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.

• Brand Name: CORAIL2 STD SIZE 12
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17108021
• MDR Text Key: 316970131
• Report Number: 1818910-2023-12092
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295168782
• UDI-Public: 10603295168782
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192946
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/12/2023

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: 3976712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 06/12/2023; 07/17/2023; 08/15/2023
• Supplement Dates FDA Received: 06/15/2023; 07/18/2023; 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Male