MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 5; HIP FEMORAL STEM

Model Number 1010-11-050

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 04/03/2023

Event Type  malfunction  

Event Description

When time to implant a sz 5 std actis stem, as it was removed from the protective packaging, a foreign coloring was noted down the side of the stem on the ha coating.

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)(6) 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.Additionally, photographs were provided.The photo investigation and visual examination cannot confirm, the reported allegation.Foreign matter that looks like blood can be observed, on the device.However, the opening conditions are not known.Additionally, other instrument stained with what appears to be the same matter can be seen on the photographs provided.Suggesting the device might have been stained, during the surgical procedure.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 no nc¿s associated with this product/lot combination.

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

Event Description

Additional information was received and stated the following: to clarify, and perhaps alert you to a manufacturing issue, the brown spots on the implant were present at the time of removal from the sterile packaging and therefore are not dried blood, unless you have blood contamination during manufacturing.I personally remove all implants from the inner packaging and never touch the ha-coated surface, only the trunnion.Upon removing the implant from the packaging, it was immediately noticed and passed off away from the sterile field.I have personally witnessed this on several actis stems, and believe i requested at least two of these to be returned for evaluation.Again, at no point was there contamination or exposure of the implant to the patient's bodily fluids and the spots were present on removal from sterile packaging.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary when time to implant a sz 5 std actis stem, as it was removed from the protective packaging, a foreign coloring was noted down the side of the stem on the ha coating.Surgeon requested to not implant this item and we opened a 2nd stem.Date of event was 4/3/2023.There was a 5 minute delay in the procedure.>> the device associated with this report was returned to depuy synthes for evaluation and photographs were also provided, please see attachments "159adc55-9eee-467f-a1f7-3587836b93e8.Jpeg, 4e5298ac-2723-4c26-ba39-ecb9fdc87dc4.Jpeg, 1c476fa1-3fd7-42d7-97e6-7ce07774de4b.Jpeg".The photo investigation and visual examination cannot confirm the reported allegation.Foreign matter that looks like blood can be observed on the device from the photos, however the opening conditions are not known.Additionally other instrument stained with what appears to be the same matter can be seen on the photographs provided, suggesting the device might have been stained during the surgical procedure.Once the device was received, the stain was already washed off probably by the sterilization process that occurs before reaching out pal lab.The overall complaint was unconfirmed as the observed condition of the [actis collared std size 5] would not contribute to the complained device issue.Based on the investigation findings, and it has been determined that no corrective and/or preventative action is required.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.Device history lot a manufacturing record evaluation was performed for the finished device cork lot# 4012726 number, and 1 non conformances unrelated to the current complaint malfunction was identified.

• Brand Name: ACTIS COLLARED STD SIZE 5
• Type of Device: 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16766152
• MDR Text Key: 313569670
• Report Number: 1818910-2023-08178
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10603295380450
• UDI-Public: 10603295380450
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202472
• 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,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1010-11-050
• Device Catalogue Number: 101011050
• Device Lot Number: D22100800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1