MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; ALT HA S CLR EXT SZ 7

Catalog Number 190-31-07

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Implant Pain (4561)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

As a result of an fda inspection conducted in jan 2020, exactech, (b)(4), has committed to remediating 3 years of complaints (2017-2020).This mdr is being submitted as part of that remediation.Information was not provided for: pt.Info.Device remains implanted.Pain due to femoral stem loosening.The collar of the femoral stem is contacting bone.It is likely that due to the contact of the collar with the calcar bone, the implant did not obtain a good initial ml mechanical press fit at the time of implantation.This situation can potentially occur secondary to over broaching of the femur.There appears to be a gap between the implant and bone on the proximal lateral stem.Per discussion with the hip team, patient may have increased their activity level before osseointegration had time to occur and micromotion from repeated early load bearing resulted in compaction of the bone on the medial side of the femoral canal and subsequent gapping on the lateral side, however this cannot be confirmed as no additional details were provided.Additionally, over-broaching the femoral canal to obtain contact between the collar of the femoral stem and calcar bone can diminish the quality of the distal press fit between the implant and bone.Design-related issues: as of 4/13/2020, exactech is aware of 42 similar complaint reports involving revision of hip components due to loosening since 2008.This issue does not appear to be design related.Mfg-related issues: exactech is not aware of any other complaints involving parts from this manufacturing lot of 16 units, which has been in the field since 2017.The manufacturing records for this device only exist in paper form and are stored in cardboard boxes at (b)(6).Due to risks associated with covid-19 transmission, the physical manufacturing records for this complaint will not be reviewed.Exactech will continue to monitor this complaint type and, if warranted, will escalate any positive trends to the corrections and removal committee (crc) for additional actions.Corrective actions are not required because loosening is listed in the product labeling, the occurrence rate is ¿very low¿, and the risk is captured in the racr.The loosening reported is likely the result of failure to obtain initial osseointegration between the bone and femoral stem.This may have been a combination of surgical technique, patient rehabilitation, or other contributing factors; however, this cannot be confirmed as the device is not available for evaluation and no other first-hand details were provided.Ifu 700-096-181: instrument inspection ¿ visually inspect the instruments for damage such as fractures; cracks; gouges; deformation; burrs; discoloration, corrosion, or rust; excessive component wear; nicks on cutting surfaces, missing or loose components; blockages in cannulae, cleaning holes or other cavities that cannot be removed via standard cleaning; worn or difficult to read markings/engravings; or other apparent damage.¿ check the function of mechanisms by actuating any levers, knobs, switches, connectors, sliding features, hinges, or other mechanical interface features.Ensure smooth operation of these features over their functional range of motion.¿ if damage, wear, or non-functioning/poorly functioning mechanisms are found, do not use the instrument, and contact the sales representative or customer service for disposition.Ifu states: the surgeon shall become thoroughly familiar with the technique of implantation of the prostheses by: (1) appropriate reading of the literature, and (2) training in the operative skills and techniques required for surgery, and (3) reviewing information regarding use of instrumentation.Device specific risks - 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.Excessive wear of the implant components secondary to impingement of components or damage of articular surfaces.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.Osteolysis.Unintended bone fractures.Limb length discrepancy.Decreased range of motion.It is a clinical standard of practice in the operating room that all instruments should be visually and functionally inspected before use, these guidelines are from standard association of peri-operative registered nurses (aorn) guidelines.Surgeons are to be familiar and knowledgeable with all instrumentation, devices and proficient with surgical techniques.This device is used for treatment not diagnosis.Based on review of all available information, there is no evidence to reasonably suggest the reported event is related to any manufacturing issues or design issues.The patient has pain and noted femoral loosening, there has not been a reported revision, nor has a revision been identified with ebi and master complaint research.Device specific risks - 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.An investigation was conducted; the loosening reported is likely the result of failure to obtain initial osseointegration between the bone and femoral stem.This may have been a combination of surgical technique, patient rehabilitation, or other contributing factors; however, this cannot be confirmed as the device is not available for evaluation and no other first-hand details were provided.

Event Description

It was reported from the us that a patient has an alteon ha in which lucencies are visible around the femoral stem, indicating stem loosening.X-ray images were provided.The patient has occasional pain.The stem has not yet been revised (when reported in (b)(6) 2020).It was reported that the surgeon was planning to see the patient in 4 months for treatment plans ((b)(6) 2020).The master complaints list was reviewed, and this device has not been revised as of 30 april 2021.Ebi was searched and there are no results for a revision for this part number or the surgeon.Multiple email requests were sent to the contacts for additional information.No additional information was provided by the contacts related to this event.

• Brand Name: EXACTECH
• Type of Device: ALT HA S CLR EXT SZ 7
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC; 2320 nw 66th ct.; gainesville 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 13932226
• MDR Text Key: 298196060
• Report Number: 1038671-2022-00296
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162732
• 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: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2022
• Device Catalogue Number: 190-31-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/27/2020
• Date Manufacturer Received: 02/27/2020
• Date Device Manufactured: 01/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1