MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER MEDIUM; HIP COMPONENT

Model Number	26000026
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient underwent in (b)(6) 2010 replacement of the right hip by means of a metal-metal prosthesis implantation, has developed pseudo-tumor from metal-metal coupling, with evidence of a cobalt dosage of 7.7 mg / l (compared to reference <1.0mg / l), causing aseptic loosening of the prosthesis and forcing it to undergo a prosthetic revision in 2014, of increased complexity due to the presence of the tumor mass.More tools since the onset of metallosis and, even more so, the development of pseudo-tumor represent clear typical consequences of metal-metal combinations.Additional information received on 12/13/2022: allegedly, reported the onset of low-grade fever, infectious causes excluded.Reported groin pain with poas weakness for about 1 year.A clinical analysis with acceptance date of (b)(6) 2014 shows results of p-chrome 0.4 ug/l and sg-cobalt 7.7ug/l.Clinical records showed that the date of the intervention for revision surgery was on (b)(6) 2014.A muscle-tendon ultrasound with date of (b)(6) 2014 for the right hip, a ct pelvis/sacroiliac with date of (b)(6) 2014 for the right hip and other studies are found from pages number 71 to 77 in the file "doc.05 cartella 06.10.2014".A histological examen dated of 10/10/2014 indicated that two materials were under examination: pericotyloid tissue biopsy and peroprosthetic tissue biopsy.However, this examination was indicated with a "clinical-anamnestic news.Previous left hip arthroplasty" therefore, there is no confirmation if the materials under examination were from the right hip.The macroscopic description of the examination and the diagnosis is found on page number 100 in the file "doc.05 cartella 06.10.2014".It is important to note that two stickers regarding acetabular cups "procotyl® l" are identified on the medical record for this patient.However, it is mentioned in the "implants tab" before the stickers sheet, that the implanted cup is pha06212, lot: 119960531.No indications about the other acetabular cup pha06210 are found throughout the files received to date.It also is important to note that two stickers regarding rim-lock metal liner cr/co are identified on the medical record for this patient.However, it is mentioned in the "implants tab" before the stickers sheet, that the implanted liner is pha04710, lot: 119983782.No indications about the other liner pha04708 are found throughout the files received to date.A screw cancellous self-tapping 6.5mm productid:18080302, lot:098700558 is found on the stickers sheet.However, it is not mentioned in the "implants tab" before the stickers sheet.Based on the implant stickers used in the revision surgery (b)(6) 2014, it appears that a neck, head and cup from wright medical have been implanted along with other components from different manufacturers.
Additional Manufacturer Narrative
See investigation attach.

• Brand Name: COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER MEDIUM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 16565555
• Report Number: 3010536692-2023-00033
• Device Sequence Number: 5498001
• Product Code: JDL
• UDI-Device Identifier: M684260000261
• UDI-Public: M684260000261
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K004043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: 26000026
• Device Catalogue Number: 26000026
• Device Lot Number: 119973176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 78 KG