MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL2 NON COL HO SIZE 12; HIP FEMORAL STEM

Model Number L20312

Device Problems Fracture (1260); Loss of Osseointegration (2408); Unintended Movement (3026)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)

Event Date 05/30/2020

Event Type  Injury  

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

It was reported that the surgeon believes that the stem fractured inter-op.The patient experienced pain from the beginning and it progressively got worse, up on review of the follow up x-rays the greater had fractured and propagated down the shaft.The stem had also subsided down.Surgeon did a reclaim but we had an issue with the 40 mm neck trial where the bolt that locks the version was stuck in the locked position.This prevented him form doing a final trial before he placed the real proximal body which was an 85 x 40.He decided to move forward with that size but when he relocated the hip it was too tight and long.We ended up removing the 85 body and switching it to a 75.The 85 body was wasted do to the failure of the trial neck.Doi: unknown, dor: (b)(6) 2020, affected site: 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.H10 additional narrative: added: h6 (patient code).H6 patient code: no code available (3191) used to capture the surgery prolonged.

• Brand Name: CORAIL2 NON COL HO SIZE 12
• Type of Device: 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: 10146948
• MDR Text Key: 194944521
• Report Number: 1818910-2020-13700
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295258032
• UDI-Public: 10603295258032
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L20312
• Device Catalogue Number: L20312
• Device Lot Number: 5343152
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 07/22/2020
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 36IDX54OD.; CORAIL2 NON COL HO SIZE 12.; DELTA CER HEAD 12/14 36MM +1.5.; ALTRX NEUT 36IDX54OD; CORAIL2 NON COL HO SIZE 12; DELTA CER HEAD 12/14 36MM +1.5
• Patient Outcome(s): Required Intervention