MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 12; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92502

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Code Available (3191)

Event Date 06/21/2020

Event Type  malfunction  

Manufacturer Narrative

(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

Could not be implanted in place.It was reported that during the total hip replacement operation, could not be implanted in place.Changed another 3l92502, could be implanted in place.The surgeon suspect the uneven coating result the size is not correct.There were no adverse consequences to the patient.No additional information could be provided.

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 : examination of the returned device found no dimensional discrepancy that would have contributed to the reported problem.A review of the device manufacturing record found no deviations or anomalies.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 5335619.A review of the device manufacturing record found no deviations or anomalies.Device history review : a review of the device manufacturing record found no deviations or anomalies.H10 additional narrative: added: e1 (facility name), h6 (patient).H6 patient code: no code available (3191) was used to capture insufficient information.

• Brand Name: CORAIL AMT COLLAR SIZE 12
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : 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: 10240326
• MDR Text Key: 197810553
• Report Number: 1818910-2020-15155
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168683
• UDI-Public: 10603295168683
• Combination Product (y/n): N
• PMA/PMN Number: K042992
• 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: 06/22/2020

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: 3L92502
• Device Catalogue Number: 3L92502
• Device Lot Number: 5335619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 07/06/2020; 08/03/2020
• Supplement Dates FDA Received: 07/09/2020; 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORAIL AMT COLLAR SIZE 12; CORAIL AMT COLLAR SIZE 12