MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL CEM STEM STD S10; CORAIL AMT CEMENTED IMPLANTS : HIP FEMORAL STEM

Catalog Number L96410

Device Problem Off-Label Use (1494)

Patient Problems Stroke/CVA (1770); Physical Asymmetry (4573)

Event Date 10/30/2023

Event Type  Injury  

Event Description

Bipolar hip replacement - three attempts of the stem took place due to the issue with the cement (palacos).During the first attempt, the surgeon was planning to use the corail stem 15cm, however the first attempt of mixing and injecting the cement went wrong and the cement syringe exploded.The surgeon had to make a second attempt and use a new cement.While trying to inject the cement to the bone, the surgeon realized that the leftovers from the first attempt were still in the femur bone and blocking the way of corail stem 15 cm.The leftovers couldn't be removed as the cement was already still and attached to the bone so the surgeon decided to opt for a smaller stem that will be short enough to not be effected by the blockage of the left overs from 1st attempt.In the 3rd attempt the surgeon used corail stem 10 cm, however while injecting a new cement, the cement syringe exploded again.The surgeon evaluated that he has enough cement in the bone, so he proceeded with placement of them smaller stem, but he couldn't choose the exact direction of the stem due to the blockage.The stability of the hip joint was good, however leg length was significantly longer.This might impact the proximal part of the cement mantle.After the surgery the patient was stable.However, a day after the surgery, the patient was admitted to intensive care unit because of the cerebral vascular incident.

Manufacturer Narrative

Product complaint # (b)(4).G4: this product code has been obsoleted and the 510k is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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: according to the information received, the surgery (bipolar hip replacement) overall went well until the last point.3 attempts of the stem took place due to the issue with the cement (palacos).During the first attempt, the surgeon was planning to use the corail stem 15cm, however the first attempt of mixing and injecting the cement went wrong and the cement syringe exploded.The surgeon had to make a second attempt and use a new cement.While trying to inject the cement to the bone, the surgeon realized that the leftovers from the first attempt were still in the femur bone and blocking the way of corail stem 15 cm.The leftovers couldn't not be removed as the cement was already still and attached to the bone so the surgeon decided to opt for a smaller stem that will be short enough to not be effected by the blockage of the left overs from 1st attempt.In the 3rd attempt the surgeon used corail stem 10 cm, however while injecting a new cement, the cement syringe exploded again.The surgeon evaluated that he has enough cement in the bone, so he proceeded with placement of them smaller stem, but he couldn't choose the exact direction of the stem due to the blockage.The stability of the hip joint was good, however leg length was significantly longer.This might impact the proximal part of the the cement mantle.Potential revision can take place if the stem ends up loose within the cement mantle.The xray pictures after the surgery is in the attachment.After the surgery the patient was stable.However, a day after the surgery, the patient was admitted to intensive care unit because of the cerebral vascular incident.We were also informed that the patient has medical histrory of afib.The product was not returned to depuy synthes, however a photo was provided for review.See attachment (dpbe23-088).The x-ray investigation revealed that corail cem stem std s10 was inserted onto the femur.Based on the surgical technique, when performing the femoral canal preparation the final size of each broach is the same as the corresponding implant.According to the surgical techniques, cemented devices are used in conjunction with the correspondent cement in order to assure the appropriate fixation of the implant, however cement is not intend to be used as a void filler during the implantation of the devices, also, the cement must be totally revised from the surgical space prior to the application of additional cement.The surgical process can be suspected for the issue reported.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the photographs attached are sufficient to draw a conclusion about the reported event.Based on the investigation findings, a potential root cause traced to user has been identified, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: CORAIL CEM STEM STD S10
• Type of Device: CORAIL AMT CEMENTED 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
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18212284
• MDR Text Key: 329067440
• Report Number: 1818910-2023-23899
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: L96410
• Device Lot Number: D22080347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CORAIL CEM STEM STD S15; UNK CEMENT (COMPETITOR); UNK CEMENT (COMPETITOR)
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR