MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK VAR/VAL 8DG SHORT COBALT CHROME; HIP COMPONENT

Model Number PHAC1252

Device Problems Corroded (1131); Material Disintegration (1177); Loss of Osseointegration (2408)

Patient Problems Osteolysis (2377); No Information (3190); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

Incident description: allegedly, patient was revised due to corrosion at the neck-stem junction of her left hip.Investigation findings: the alleged complaint is not confirmed.This incident was received through a legal claim.The products were not returned, and no images or surgical notes were provided for investigation to confirm the complaint.Review of the device history record (dhr) for the stated lots indicates that these products met all acceptance criteria at the time of manufacturing.There have been no manufacturing deviations identified which would affect the performance of the device.There is not a trend for this product/lot.Review of the complaint database reveals that this is the first reported complaint for the stated lots for this issue.This failure mode is listed in the device package insert and risk documentation.The microport hip systems lists "allergic reactions to materials; metal sensitivity; or reactions to wear debris that may lead to histological reactions, pseudotumor and aseptic lymphocytic vasculitis-associated lesions (alval)" as a potential adverse effect.It also lists, "dislocation, migration and/or subluxation of prosthetic components from improper positioning, trauma, loss of fixation and/or muscle and fibrous tissue laxity." these products had been implanted for approximately 52 months at the time of revision.Concerning the cocr modular neck, the incident description describes an issue addressed by corrective and preventive action (capa) #(b)(4).This capa found that, "the potential for a patient reaction when implanted with a profemur® cocr modular neck is a known risk for this product technology.A combination of patient and surgical factors can contribute to an elevated risk of an adverse patient reaction.These factors include, but are not limited to, patient sensitivity, surgical technique, patient weight and activity level." no further evaluations can be made without return of the products or receipt of other clinical information.

Event Description

Allegedly, patient was revised due to elevated levels of chromium and cobalt , during the surgery dr.(b)(6) removed the previously implanted neck and head, noting "mild erosion at the neck".After the revision the patient reported at least 3 dislocations.

Event Description

Allegedly, patient was revised due to elevated levels of chromium and cobalt , during the surgery dr.Grandic removed the previously implanted neck and head, noting "mild erosion at the neck".After the revision the patient reported at least 3 dislocations.Additional information received on 01/29/2021: lot numbers used for primary surgery were confirmed against medical records.Allegedly, patient's x-rays including an ap and lateral performed on (b)(6) 2019 were interpreted of the right hip demonstrating well fixed/well aligned total hip arthroplasty without evidence of failure or wear or loosening.No dislocation or instability events since (b)(6) 2019.

Manufacturer Narrative

Section b5: event description; section d4: lot number of device; section g4: reporter source update; section h6: adverse event problem codes.

Event Description

Allegedly, patient was revised due to elevated levels of chromium and cobalt, during the surgery dr.(b)(6) removed the previously implanted neck and head, noting "mild erosion at the neck".After the revision, the patient reported at least 3 dislocations.Additional information received on 01/29/2021: lot numbers used for primary surgery are confirmed.Allegedly, patient's x-rays including an ap and lateral performed on (b)(6) 2019, were interpreted of the right hip demonstrating well fixed/well aligned total hip arthroplasty without evidence of failure or wear or loosening.No dislocation or instability events since (b)(6) 2019.Additional information received on 7/21/2022: it is indicated that patient had also pain and evidence of a pseudotumor at the time of its "first revision surgery" on (b)(6) 2019.Also, at the time of her first revision surgery only the head and neck were revised and replaced with a pha04410 femoral head biolox delta ceramic 12/14 - 32 m and pha01252 profemur® neck 8dg var/val short.Patient's first revision was necessary because the device failed due to corrosion at the neck-stem junction.It was discovered corrosion of the profemur cocr modular neck where it seated in the pocket of the modular stem.On or about (b)(6) 2021, patient reported for a revision surgery of the right total hip arthroplasty, revision of both the acetabular and femoral components.Surgeon recommended this second revision surgery due to recurrent instability with dislocations.During revision surgery, surgeon determined the only way to safely remove the modular stem was to perform an extended trochanteric osteotomy (eto), which required four dall miles cables with the use of a 240 mm revision stem.Second revision surgery was necessary due to the failure of the profemur total hip system causing metal wear debris and corrosion, elevated metals ions and pseudotumor, the need for first revision surgery, soft tissue damage and loss, along with weakening of the hip joint resulting in frequent dislocations and recurrent instability.This second revision surgery regarding the head and neck (implanted during patient's first revision surgery) has been captured under microport incident group (b)(4).

• Brand Name: PROFEMUR® NECK VAR/VAL 8DG SHORT COBALT CHROME
• 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: 10229596
• MDR Text Key: 201051341
• Report Number: 3010536692-2020-00464
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684PHAC12521
• UDI-Public: M684PHAC12521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHAC1252
• Device Catalogue Number: PHAC1252
• Device Lot Number: 1417979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/15/2020
• Date Manufacturer Received: 06/15/2020
• 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; Other
• Patient Age: 86 YR
• Patient Sex: Female