MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT SZ9 125 STD COL; CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM

Model Number L971209

Device Problem Missing Information (4053)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).The packaging label was not missing from the corail stem.Rather, the implant identification sticker, which is used to identify the type of implant received within the patient¿s medical records, was missing the information that identified the stem as ¿125 degrees,¿ this was indicated by the surgeon.A product investigation will be conducted, once complete, the findings will be submitted.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 the a size 9 125 degree size 9 standard corail was trialed and implanted.Post-op while dictating the surgeon noticed the implant sticker said size 9 standard corail.No mention of it being a 125 degree standard corail.The implant box was pulled from the trash to confirm it was a 125 degree stem.Also pulled records from a previous 125 degree standard corail case she did the week prior to confirm that the sticker from it did indeed say 125 degree.It did.That implant was a size 14 125 degree standard corail.She is wanting to know why we would put 125 degree on some sizes and not others as well as the potential to think there was another style of stem implanted.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device or device labeling has been provided for examination.The investigation did confirm the 125 degree designation is not included on the inner patient labeling.This is by design.There has been no change to the labeling for this product code since calendar year 2011.No error in processing or labeling is identified.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.Device history lot: lot 9026641.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: CORAIL AMT SZ9 125 STD COL
• Type of Device: CORAIL LINE EXTENSION IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10797155
• MDR Text Key: 215036891
• Report Number: 1818910-2020-24061
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295455394
• UDI-Public: 10603295455394
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

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 Model Number: L971209
• Device Catalogue Number: L971209
• Device Lot Number: 9026641
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORAIL AMT SZ9 125 STD COL; CORAIL AMT SZ9 125 STD COL
• Patient Age: 50 YR