MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ACETABULAR CUP; HIP COMPONENT

Model Number PHA06212

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event 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.Only part numbers and lot numbers for the cup and stem were provided.

Manufacturer Narrative

B.5: additional information in description / section d.6a and d.6b: implant and explant date updated/ section h.6 health code updated and investigation codes updated.

Event 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 on (b)(6) 2014".A histological examen dated of (b)(6) 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 product id: 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.

• Brand Name: ACETABULAR CUP
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 15495044
• MDR Text Key: 300700474
• Report Number: 3010536692-2022-00341
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA06212
• Device Catalogue Number: PHA06212
• Device Lot Number: 119960531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/05/2022
• Date Manufacturer Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention