MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CORAIL2 NON COL HO SIZE 9; HIP FEMORAL STEM

Catalog Number L20309

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Numbness (2415); Metal Related Pathology (4530)

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer.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.

Event Description

Medical records received ad (b)(6) 2023.On (b)(6) 2010, right hip arthroplasty to address avascular necrosis of the right hip (sticker page 35 of 672) includes a depuy products.The femoral head was ceramic and liner was metal.Surgery was completed successfully.(b)(6) 2017 lab values were: cobalt blood 12.0 mcg/l.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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).A manufacturing records evaluation (mre) was not performed.

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).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).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: d4 (expiration date).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records (b)(4) entire record were reviewed by clinician.On (b)(6) 2010, the patient had a right total hip arthroplasty to address avascular necrosis of right femoral head.Depuy components were implanted.On (b)(6) 2010 medical record notes the patient is 3 months follow-up for right gtb injection.The patient states the injection only provided temporary relief.Patient notes having pain in the groin and buttock.The patient¿s primary diagnosis is right trochanteric bursitis.(b)(6) 2010 patient continues to have right hip pain.Patient is to continue physical therapy.On (b)(6) 2017, lab results were listed as cobalt levels were at 12.No unit of measurement provided.The physical assessment noted the patient had bilateral leg pain after bilateral total hip now with some numbness and tingling as well as weakness in the patient¿s left leg.The plan included mri of her lumbar spine to look for a possible herniated disk.(b)(6) 2017, medical records note the patient has low back pain and bilateral hip pain.No invasive treatment noted.(b)(6) 2019, the patient has diagnosis code of pain in right hip and pain in left hip.No invasive treatment (b)(6) 2019, medical records note the patient¿s cobalt chromium levels were both elevated, with no quantities provided.The patient had a mars mri that shows fluid collection around her right hip consistent with metallosis.(b)(6) 2019 the patient had a revision right total hip arthroplasty (acetabular component) to address metallosis with metal on metal articulation.The acetabular cup was note to be well fixed, but was revised.Competitor component implanted during this procedure.Doi: (b)(6) 2010; dor: (b)(6) 2019; right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Update 11-mar-2024 received did not have any additional details to be added in investigation.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: CORAIL2 NON COL HO SIZE 9
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17699519
• MDR Text Key: 322849280
• Report Number: 1818910-2023-18272
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295258001
• UDI-Public: 10603295258001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192946
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/07/2023

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 Expiration Date: 11/05/2012
• Device Catalogue Number: L20309
• Device Lot Number: 2478078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 08/17/2023; 09/15/2023; 10/16/2023; 12/15/2023; 02/26/2024
• Supplement Dates FDA Received: 09/14/2023; 09/18/2023; 10/18/2023; 12/20/2023; 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2007
• 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: APEX HOLE ELIM POSITIVE STOP.; DELTA CER HEAD 12/14 36MM +1.5.; PINNACLE MTL INS NEUT36IDX50OD.; PINNACLE SECTOR II CUP 50MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 135 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American