MAUDE Adverse Event Report: EXACTECH, INC HOLDING PIN HEADLESS SHARP POINT LONG 4 PACK

Catalog Number 201-78-14

Device Problems Degraded (1153); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Joint Disorder (2373); No Code Available (3191)

Event Date 10/28/2015

Event Type  Injury  

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the device was not returned for evaluation.

Event Description

Index surgery: (b)(6) 2017.Revision of the left knee due to poly wear.

Event Description

It was reported that a patient experienced a left knee revision due to prosthesis wear.The patient had developed mechanical symptoms in his knee joint and his radiographs demonstrated evidence of subluxation of his femur on his tibia consistent with wear of the polyethylene liner.In surgery it was found that the polyethylene liner had worn in the posteromedial corner such that the femoral and the tibial components for rubbing against one another causing the metallosis, the entire knee replacement had to be revised.The parapatellar capsule was opened, it was evident that the patient had a significant amount of metallosis within the knee joint that was covering the entire synovium.The fluid was sent for gram stain, culture and sensitivity, although there was no evidence of infection (the results were not provided).An extensive synovectomy was performed starting in the medial gutter, extending into the suprapatellar pouch, and then into the lateral gutter, the infrapatellar tendon was also debrided.The patient tolerated the procedure well and postoperatively was transferred to the recovery room in satisfactory condition.There were no complications.No additional information was provided about the patient or event.Reported :index surgery: (b)(6) 2017.Revision of the left knee due to poly wear.Correction: index surgery: (b)(6) 2007.The surgeon reported gross loosening of both femoral and tibial components and significant metallosis covering the entire synovium due to wear of the polyethylene insert so that the femoral and tibial components were rubbing together.This is one of six products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00100, 1038671-2017-00467, 1038671-2017-00470, 1038671-2017-00471 and 1038671-2019-05028.

Manufacturer Narrative

The complained products were no received for analysis.The reported malfunction of prosthesis wear was not confirmed.The frequency of occurrence ranking scale is very low; therefore, this does not appear to be design-related.The company is not aware of receiving any other complaint reports involving parts from this manufacturing lot of tibial inserts.The device history record was reviewed, and all parts were accepted with conformance to the print specifications.Therefore, this issue does not appear to be manufacturing-related.There were no user-related conditions reported.The revision reported was likely the result of excessive tibial insert wear.The underlying cause of the wear could not be determined because the component was not returned for evaluation and no x-rays were provided.In review of labeling, op techs and ifus: device specific risks include: fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.Metal sensitivity reactions or other allergic/histological reactions to implant materials; possible detachment of the coating(s) on the components, potentially leading to increased debris particles; adverse events associated with the use of bone cement; disassociation of modular components; & excessive wear of the implant components secondary to impingement of components or damage of articular surfaces.It is a known complication that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.The patient risk/clinical factors include the fact that the patient is young and has bilateral knee arthroplasties which causes a stress on the devices from a biomechanical standpoint.There are underlying patient conditions such as joint maladies also evidenced by bilateral tka at 55 years of age.This device is used for treatment not diagnosis.Section(s): information has been requested on the event and patient.No new information has been provided.

• Brand Name: HOLDING PIN HEADLESS SHARP POINT LONG 4 PACK
• Type of Device: HOLDING PIN
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 6743577
• MDR Text Key: 81014128
• Report Number: 1038671-2017-00469
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 08/04/2012
• Device Catalogue Number: 201-78-14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR