MAUDE Adverse Event Report: DEPUY IRELAND 9616671 CORAIL AMT SZ14 135 HIGH COL; CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

Model Number L971114

Device Problems Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)

Patient Problem No Code Available (3191)

Event Date 07/29/2020

Event Type  malfunction  

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 Description

Procedure: primary total hip replacement operating side: left hip.Surgical delay: yes, 5 mins for replacement implant to be taken from implant room, checked and opened.Event: punctured inner packaging of corail stem.Upon removal of the inner packaging of the corail stem from its outer box it was evident that there was a distinctive hole between the paper seal and the plastic box containing the sterile implant.On closer examination it was clear that this hole had punctured all the way through the paper therefore deeming the implant contained within the plastic box unsterile.Another implant was opened and used in its place.

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: 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 #
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> (b)(4).Investigation summary
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> no device associated with this report was received for examination.Examination of provided photographs confirms the reported observation.The investigation is unable to conclusively determine a root cause using photographs.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.H6 patient code: no code available (3191) used to capture the prolonged surgery and insufficient information.

• Brand Name: CORAIL AMT SZ14 135 HIGH COL
• Type of Device: CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 10390909
• MDR Text Key: 202382830
• Report Number: 1818910-2020-17863
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295455332
• UDI-Public: 10603295455332
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2020

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 Expiration Date: 08/31/2023
• Device Model Number: L971114
• Device Catalogue Number: L971114
• Device Lot Number: 8848649
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 08/12/2020; 10/26/2020
• Supplement Dates FDA Received: 08/19/2020; 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1