MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE POST STAB FEMORAL SIZE 5 NONPOROUS; KNEE COMPONENT

Model Number KFPSNP50

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

The alleged complaint could not be confirmed.This patient was indicated to have been revised due to stiffness approximately 43 months after the primary operation.All components were revised.The revised products were not returned to microport, and no radiographs or operative notes were provided to confirm this complaint.Review of the device history record for this lot indicates that this product met all acceptance criteria at the time of manufacturing.The microport knee systems package insert (150806-2) lists "inadequate range of motion due to improper selection or positioning of components, periarticular calcification, flexion contracture" as a possible adverse effect of total knee arthroplasty.There were no trends identified per mpo trending procedures.No further conclusions can be made from the available information.This issue will continue to be monitored through complaint tracking.Methods: device not returned.Analysis of production records.Trend analysis.Results: no findings available.Conclusions: device met specification.Device was used for treatment.Known inherent risk of device.

Event Description

Allegedly, patient was revised due to stiffness.Revision njr number: (b)(4).Side: r.Primary asa: p2 - mild disease not incapacitating.

• Brand Name: ADVANCE POST STAB FEMORAL SIZE 5 NONPOROUS
• Type of Device: KNEE 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: 12240154
• MDR Text Key: 264076809
• Report Number: 3010536692-2021-00410
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: M684KFPSNP501
• UDI-Public: M684KFPSNP501
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K973524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KFPSNP50
• Device Catalogue Number: KFPSNP50
• Device Lot Number: 1648110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2021
• Date Manufacturer Received: 07/14/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention