MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 CORAIL AMT COLLAR SIZE 13; CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM

Model Number 3L92503

Device Problems Fracture (1260); Naturally Worn (2988); No Apparent Adverse Event (3189)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Ambulation Difficulties (2544); Not Applicable (3189); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2020

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

It was reported that the corail stem.Trunnion broke off the body of the stem.Doi: (b)(6) 2014, 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.

Event Description

Additional information received states that the affected side was the right hip.

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.

Event Description

On (b)(6) 2014, the patient received a right tha to treat pain secondary to osteoarthritis.Primary operative notes were not provided.Post-operative clinic notes dated (b)(6) 2015 to (b)(6) 2015 stated that the patient presented with progressive pain and difficulty walking of the right hip.Patient reported he fell sometime in january or (b)(6) of 2015.Patient received serial radiographic studies that revealed iliopsoas tendonitis, intermittent edema, and right gluteal heterotopic ossification.The right leg was 10 mm shorter than the left, which the physician attributed the pain and walking difficulty to.The patient received several steroid injections to treat the pain.These measures failed and the patient was referred for revision surgery to treat the underlying limb asymmetry.On (b)(6) 2015, the patient received a right liner and head revision to treat instability, subluxation, pain, tendonitis, heterotopic ossification, edema, and walking difficulty secondary to a 10 mm limb asymmetry following primary tha.Upon entering the joint, significant scar tissue was debrided from the periarticular space.The liner was noted to be slightly loosened and easily removed from the cup.The cup was well-fixed and retained.The acetabular screw was removed to accommodate the new articulating surfaces.The stem was well-fixed and retained.The head was revised with a longer neck to correct the limb asymmetry.The surgeon noted that a titanium sleeve was used to secure the new ceramic head.Intraoperatively, the patient had to be switched from spinal anesthesia to general anesthesia with intubation to gain additional muscle relaxation.The patient received a depuy poly liner and ceramic head.The procedure was completed without complications.Clinic notes and radiology reports dated (b)(6) 2016 to (b)(6) 2016.The patient presented with persistent pain, trochanteric bursitis, heterotopic ossification, and walking difficulty following a right hip revision surgery.Serial radiographic studies identified a well-fixed, well-aligned right tha with minimal gluteal extraskeletal ossification.The patient received three pain relief injections to treat the pain on (b)(6) 2016, (b)(6) 2016, and (b)(6) 2016.The surgeon noted that the patient was referred for re-evaluation of his medication for depression.The injections and medication adjustment were successful.(b)(6) 2020, the patient received a right tha revision to treat pain and walking difficulty secondary to fracture of the corail 13 ka stem at the trunnion.Upon entering the joint, hemarthrosis was evacuated.The cup was slightly loose superiorly, and revised.The stem was well-fixed, with a fracture at the neck, and revised.There was no reported product problem with the revised liner and head.The patient received a competitor revision modular system with competitor cerclage of the femur.Doi: (b)(6) 2014, dor: (b)(6) 2015 (liner and head), doe: (b)(6) 2016 (steroid injections for pain) and dor: (b)(6) 2020 (all components) right hip.

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.Re-captured patient codes.No code available (3191) is used to capture device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After review of the medical records, the patient was revised to address right failed total hip arthroplasty for femoral component fracture.Operative note reported of broken head and trunnion and possible locking mechanism issue of the cup and liner.It was also indicated that there was a metal debris from the removal of the stem.Added facility name and legal attorney.The head and liner that were implanted on (b)(6) 2015, was reported under (b)(4).Doi: (b)(6) 2014.Dor: (b)(6) 2020.Right hip (second revision).

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.H10 additional narrative: added: b5 and h6 (device codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.E3 initial reporter occupation: lawyer.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : update 9-jun-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.Visual examination of the provided photographs and x-ray images confirmed the reported event.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.Device history lot : 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # (b)(4) mrn 1818910-2020-14499 is being retracted since it was found to be a duplicate of mrn 1818910-2021-15036.Mrn 1818910-2021-15036 will be kept for investigation purposes.

• Brand Name: CORAIL AMT COLLAR SIZE 13
• 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
• Manufacturer (Section G): DEPUY FRANCE SAS 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10200188
• MDR Text Key: 196586976
• Report Number: 1818910-2020-14499
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295168690
• UDI-Public: 10603295168690
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042992
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 3L92503
• Device Catalogue Number: 3L92503
• Device Lot Number: 5231322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 40IDX60OD; DLT TS CER HD 12/14 40MM +1.5; PINN CAN BONE SCREW 6.5MMX40MM; PINN SECTOR W/GRIPTION 60MM; PINN SECTOR W/GRIPTION 60MM; UNKNOWN HIP ACETABULAR LINERS(POLY LINER); UNKNOWN HIP FEMORAL AUGMENT (TITANIUM SLEEVE); UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL HEAD(CERAMIC HEAD); UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 109 KG