MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT

Model Number PHA01254

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

The alleged complaint could not be confirmed.It was indicated that this patient was revised due to aseptic stem loosening, adverse reaction to particulate debris, and a head/socket mismatch.The revised products were not returned for investigation.No radiographs, operative notes, or clinically relevant documentation was provided to confirm the complaint.Review of the device history record for this lot indicates that this product met all acceptance criteria at the time of manufacturing.This patient has a biolox delta ceramic femoral head articulating with a biolox alumina ceramic acetabular liner, which was stated to have been a mismatch.These products are the appropriate sizes, and even though the ceramic bearings are different models of ceramic, these products are indicated for use with each other as stated in the package insert for these products (150803-8).There is no information to assess the alleged tissue reaction due to wear debris.The microport hip systems package insert (150803-8) lists "dislocation, migration and/or subluxation of prosthetic components from improper positioning, trauma, loss of fixation and/or muscle and fibrous tissue laxity" as possible adverse effects of total hip arthroplasty.It also 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)." there were no trends identified per mpo trending procedures.No further conclusions can be made regarding this event.This issue will continue to be monitored through complaint tracking.

Event Description

Allegedly, patient was revised due to loosening -stem.Head/socket mismatch.Adverse soft tissue reaction to particulate debris.Revision njr number: (b)(4).Side:l; primary asa: p2 - mild disease not incapacitating.

• Brand Name: PROFEMUR MODULAR FEMORAL NECK
• 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: 12132689
• MDR Text Key: 260415909
• Report Number: 3010536692-2021-00367
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHA01254
• Device Catalogue Number: PHA01254
• Device Lot Number: 28547629
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/17/2021
• Date Manufacturer Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention