MAUDE Adverse Event Report: DEPUY IRELAND 9616671 CORAIL AMT COLLAR SIZE 13; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92503

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Foreign Body Reaction (1868); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 07/22/2020

Event Type  Injury  

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

The patient was revised to address metallosis and osteolysis from a ceramic head on a metal liner articulation.Stem, head and liner were removed.Cup was shown to still have good purchase so the cup remained in place.It was also indicated that there was a loosening of the stem at bone to implant interface.Doi: unknown, dor: (b)(6) 2020, affected side: unknown.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary =no device associated with this report was received for examination.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.

• Brand Name: CORAIL AMT COLLAR SIZE 13
• Type of Device: CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 10355841
• MDR Text Key: 201349804
• Report Number: 1818910-2020-17342
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168690
• UDI-Public: 10603295168690
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3L92503
• Device Catalogue Number: 3L92503
• Device Lot Number: 2195423
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINNACLE MTL INS NEUT40IDX56OD; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD; PINNACLE MTL INS NEUT40IDX56OD; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention